data reviewer

KBI Biopharma

<div><div>At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact.</div><div></div><div>
Position Summary:</div><div>
This is a Data Reviewer position in Analytical and Formulation Sciences department reporting to Project Leader.</div><div></div><div>
Responsibilities:</div><div>
Perform data review for contract services projects, including GMP testing for internal and external manufacturing and stability studies, analytical and formulation development for monoclonal antibodies, recombinant proteins and peptides.</div><div></div><div>
Follow manager&rsquo;s instructions to complete job responsibilities and spend approximately 95% time on data review for assay categories as outlined in Job Responsibility section. Understand principles of the technologies in scope for data review at respective job title level. Verify that calculations and documented information are correct, complete and accurate in accordance with guiding documents and internal procedures. Maintain and update knowledge of relevant instrumentation and cGMP standards.</div><div></div><div>
Make detail observations and report documentation corrections required to analysts and their managers, as needed. Contribute to review related feedback, including review group needs, to the functional management. Work with functional management to improve review cycle time.</div><div></div><div>
Data reviewer job responsibilities and approximate percent of time are allocated based on the assay complexity level are:</div><div>
1. Logbooks and simple assays without calculations Instrument or Solution Logbooks, Appearance, Color, Clarity, Turbidity, pH, Osmolality, particle analysis KF, Viscosity, HIAC, MFI - 20%</div><div>
2. Spectrophotometric assays UV, SoloVPE, Gel analysis SDS-PAGE, Western Blot, IEF, ELISA, BCA - 75%</div><div>
3. Maintain and update knowledge of technologies and cGMP standards 5%</div><div></div><div>
Requirements:</div><ul><li><div>
Must have background in biopharmaceutical analytical testing, understand cGMP standards. Demonstrate strong communication and interpersonal skills.</div></li><li><div>
BS/BA with minimum 4 years of related experience or MS/MA with minimum 2years of related experience.</div></li><li><div>
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.</div></li><li><div>
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, percent, molarity and other common calculations used in biochemistry. Ability to generate and interpret graphs and plots.</div></li></ul><div></div><div>
Salary: $63,000-$86,900</div><div>
Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate&rsquo;s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs.</div><div></div><div>
About KBI:</div><div>
KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit <div>www.kbibiopharma.com</div>.</div><div></div><div><i><br>
KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds &ndash; regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status &ndash; and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.</i></div><div></div><div><i><br>
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.</i></div><div></div><div><i>
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.</i></div><div></div><div><i>
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.</i></div></div>

KBI: US - Data Reviewer/Senior Research Associate

Intertek

<div></div><div><p><b>Label Reviewer</b></p><p>
Intertek, helping companies around the world develop products to be used safely by millions of people every day, is searching for reliable candidates with a strong attention to detail to join a new project team dedicated to reviewing product labels for a large retailer. These positions will be part of Intertek&rsquo;s Assuris team, and is a fantastic opportunity to begin a quality assurance career in retail consumer goods.</p><p><i>
Intertek Assuris is an unparalleled team of industry-leading experts providing science-based assurance in quality, safety, and sustainability. Our global network of scientists, engineers, and regulatory specialists provides support to navigate complex scientific, regulatory, environmental, health, safety, and quality challenges throughout the value chain. Through our regulatory, scientific and industry insights, we empower companies with solutions designed to enable market access, assess and mitigate risk, preserve and promote human health, and protect the environment.</i></p><p><b>
What are we looking for?</b></p><p>
The <b>Label Reviewer </b>position is responsible for reviewing product labels and documentation against regulatory, quality, and internal standards. Documentation of these findings is highly detailed, and familiarity with MS Office products is a plus. The role requires accuracy, process discipline, and comfort working in a high-volume, deadline-driven environment. Employees will have some flexibility with scheduling requirements, but may be required to work weekends and Holidays from time-to-time.<br>
<br>
This position is fully remote. However, we are prioritizing candidates located near Bentonville, AR, who may be available for occasional onsite visits.</p><p><b>
Job Title:</b> <b>Label Reviewer, Part-time or Full-time</b></p><p><b>
Location: Remote</b></p><p><b>
Salary &amp; Benefits Information</b></p><p><b>
The base wage or salary range for this position is $23</b><b> - $26 per hour</b><b>. Individual compensation packages are based on a variety of factors unique to each candidate including skill set, experience, qualifications, and other job-related reasons.</b></p><p>
In addition to competitive compensation packages, when working with Intertek you can expect benefits including medical, dental, vision, life, disability, 401(k) with company match, generous vacation / sick time (PTO), tuition reimbursement and more for full-time positions.</p><p><b>
What you&rsquo;ll do:</b></p><p>
The <b>Label Reviewer</b> position is responsible for the following duties:</p><ul><li>
Review labels, documents, and records against checklists, SOPs, and regulatory standards.</li><li>
Identify discrepancies, formatting errors, or missing substantiation, and document findings clearly.</li><li>
Maintain accurate, audit-ready records of reviews and corrections.</li><li>
Meet daily/weekly throughput quotas while sustaining accuracy.</li><li>
Log and track work in spreadsheets, databases, and workflow dashboards.</li><li>
Escalate unclear, ambiguous, or high-risk issues to senior reviewers or experts.</li><li>
Collaborate cross-functionally with other review teams (Formatting, Ingredient, Claims, QA/QC).</li><li>
Communicate findings and updates clearly through email, messaging, and shared systems.</li><li>
Work independently and effectively in a remote, process-driven environment.</li></ul><p>
This position outline is a general guideline and does not represent all encompassing details. The position assumes that the incumbent has both the mental and physical requirements to carry out the above defined duties.
</p><p><b>What it takes to be successful in this role:</b></p><ul><li>
High School Diploma or equivalent</li><li>
1+ years of hands-on experience thriving in a fast-moving, deadline-focused role.</li><li>
1+ years of working on a computer with technical or tedious workload</li><li>
Strong level of comfort with Microsoft Office products (Excel, Word, Outlook)</li><li>
Strong attention to detail and accuracy across repetitive tasks.</li><li>
Ability to interpret structured guidance and apply rules consistently.</li><li>
Proficiency with spreadsheets, databases, and workflow/task management tools.</li><li>
Excellent written communication and documentation skills.</li><li>
Reliable, self-directed, and able to meet deadlines in a remote environment.</li><li>
Comfortable handling confidential or sensitive product information.</li><li>
This is a remote position; however, applicants must reside in and be able to legally work in the United States.</li></ul><p><b>
Preferred Requirements &amp; Qualifications:</b></p><ul><li>
Completed an Associate&rsquo;s degree program, or higher</li><li>
2+ years of experience in a time-sensitive, high-paced professional setting, such as an office</li><li>
Experience with QC/QA work</li><li>
Experience in regulatory compliance, document review, quality assurance, or related fields</li><li>
Availability to work weekend and Holiday hours is a plus.</li></ul><p></p><p><b><br>
Intertek: Total Quality. Assured.</b></p><p>
Intertek is a world leader in the Quality Assurance market, with a proven, high-quality business model and a global network of customer-focused operations and highly engaged subject matter experts. With passion, pace, and precision we work to exceed our customers&rsquo; expectations, while engaging with our employees to be 10X in their performance and professional growth.</p><p>
Intertek is a drug-free workplace. As a condition of employment, certain positions may be required to pass a pre-employment drug test based on the type of work that will be performed.</p><p>
For individuals with disabilities who would like to request accommodation, or who need assistance applying, please email hr.eeo@intertek.com or call 1-877-694-8543 (option #5) to speak with a member of the HR Department.</p><p><b>
Our Culture of Total Quality Assurance</b></p><p>
Intertek promotes a culture where motivated, customer-oriented employees can flourish, experience professional fulfillment, and reach their highest potential. At Intertek, we exercise our spirit of innovation, the passion of our people and our unmatched customer commitment to realize our purpose of making the world an ever better, safer, and more sustainable place for all.</p><p>
A career with Intertek offers rewarding opportunities to help companies around the world develop products to be used safely by millions of people every day. Intertek is the trusted advisor to many of the world&rsquo;s leading brands, companies, and governments, and has earned a reputation for accuracy, reliability, integrity, and technical competence. Working at Intertek means joining a global network of state-of-the-art facilities and passionate people who deliver superior customer service with a purpose of bringing quality, safety, and sustainability to life.</p><p><b>
We Value Diversity</b></p><p>
Intertek&rsquo;s network of phenomenal people are our greatest assets, and the diversity they bring fuels our success. Intertek is an Equal Employment Opportunity Employer that values inclusion and diversity. We take affirmative action to ensure all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other legally protected characteristics.</p><p></p><p><br>
#LI-DR</p><ul><li><i>Intertek does not accept unsolicited approaches from agencies and will not pay a fee for any placement resulting from the receipt of an unsolicited resume.</i></li></ul>
Intertek&rsquo;s Health, Environmental &amp; Regulatory Services (HERS) business line is renowned for its high-quality solutions delivered through its global network of world-class scientific, engineering, toxicological and regulatory experts. Additionally, HERS provides regulatory compliance support, as well as industry-agnostic solutions pertaining to sustainability, quality, and safety, empowering companies to mitigate risks and make informed decisions relating to their products and processes.Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification (ATIC) solutions for our customers' operations and supply chains. Working at Intertek means joining a global network of state-of-the-art facilities and passionate people who deliver superior customer service with a purpose of bringing quality, safety, and sustainability to life.</div>

Label Reviewer

Movate

<b>Location:</b> Hyderabad
<br><b>Experience:</b> 2+ years
<br><b>Education:</b> Bachelor’s degree in journalism, Communications, Media Studies, or related field
<br><b>No of openings:</b> 75+ Openings
<br><br>
<b>Position Overview:</b><br>
We are looking for an experienced and detail-oriented Video Content Quality Reviewer to join our video production team. The ideal candidate will possess a strong understanding of video production standards, ensuring all video content meets the team’s editorial, technical, and creative requirements including spelling and grammar check, regional alignment and overall quality. This role involves reviewing and approving videos for accuracy, consistency, and compliance with quality benchmarks before they are published on digital platforms.
<br><br>
<b>Key Responsibilities:</b><br>
Content Review & Approval
<br><br>
Ensure videos align with the template, style, have proper background music and voiceovers as per mandated requirements.
<br>Cross-checking scripts and grammar, pronunciation, displaying a strong command over the English language across the visuals, and audio used to verify consistency.
<br><br>
Technical Quality Assessment
<br><br>
Inspect videos for technical quality, including resolution, color grading, transitions, audio levels, and overall synchronization.
<br>Flag and guide corrections for issues such as poor framing, sound inconsistencies, or graphical errors.
<br>Confirm that all content adheres to digital platform standards.
<br><br>
Compliance & Ethical Standards
<br><br>
Ensure videos meet legal, ethical, and regulatory guidelines, including copyright and fair use laws.
<br>Verify that sensitive topics are handled with appropriate editorial care.
<br>Confirm compliance with time limits and technical constraints specific to different platforms.
<br><br>
Collaboration & Feedback
<br><br>
Work closely with video producers and editors, to provide constructive feedback.
<br>Develop and maintain quality checklists and guidelines for consistent reviews.
<br><br>
<b>Requirements:</b><br>
Preferably a Bachelor’s degree in Journalism, Communications, Media Production, or a related field.
<br>Minimum 2+ years of experience in video editing, production, or quality assurance within a media organization.
<br>In-depth understanding of journalistic principles and editorial integrity.
<br>Proficiency with video editing software (e.g., Adobe Premiere Pro, Final Cut Pro) and quality assurance tools.
<br>Strong analytical and reporting skills for assessing video content against set standards.
<br>Usage and familiarity with AI-based tools to for visualization or reporting
<br>Knowledge of broadcasting and digital video requirements, including social media optimization.
<br>High attention to detail with a commitment to accuracy.
<br>Excellent communication and interpersonal skills to provide actionable feedback.
<br>Ability to work under tight deadlines and manage multiple projects simultaneously.
<br>Familiarity with visual storytelling and audience engagement techniques.
<br><br>
Why Join Us?
<br><br>
Be part of a leading AI-enabled video production team
<br>Collaborate with a team of talented professionals in a fast-paced and innovative environment.
<br>Shape the quality and impact of video content that informs and inspires audiences.
<br>Follow Us On LinkedIn To Know About Our Latest Job Openings!
<br>Submit the form below to apply
<br><br>
Name(Required)
<br>Email(Required)
<br>Phone(Required)
<br>Do you have experience reviewing video content for quality and consistency?(Required)
<br>Yes
<br>No
<br>Are you comfortable working in fast-paced production environments with tight deadlines?(Required)
<br>Yes
<br>No
<br>Do you have experience in video content review for grammar, pronunciation, and script accuracy?(Required)
<br>Yes
<br>No
<br>Are you proficient in identifying voice-over pronunciation and tone issues in English?(Required)
<br>Yes
<br>No
<br>Can you detect and suggest corrections for grammatical and contextual errors in English scripts?(Required)
<br>Yes
<br>No
<br>Do you have experience with American English voice standards and cultural nuances?(Required)
<br>Yes
<br>No
<br>Have you worked with tools like Adobe Premiere, After Effects, or video QA platforms?(Required)
<br>Yes
<br>No
<br>Do you have experience flagging issues related to media mismatch (e.g., irrelevant visuals, incorrect sports teams or people shown)?(Required)
<br>Yes
<br>No
<br>Are you familiar with using internal review platforms or annotation tools for video QA?(Required)
<br>Yes
<br>No
<br>Have you reviewed video content for cultural alignment (e.g., ensuring content is appropriate for a U.S. audience)?(Required)
<br>Yes
<br>No
<br>Are you confident in identifying sensitive or inappropriate content that may not align with brand guidelines?(Required)
<br>Yes
<br>No
<br>Do you have experience in documenting feedback using structured review comments or forms?(Required)
<br>Yes
<br>No
<br>Have you worked with cross-functional teams like scriptwriters, VJs, or video editors to resolve review comments?(Required)
<br>Yes
<br>No
<br>Are you comfortable participating in calibration sessions to align with team-wide quality standards?(Required)
<br>Yes
<br>No
<br>Current Location(Required)
<br>Attach Resume(Required)
<br><b>Accepted file types:</b> pdf, docx, doc, Max. file size: 10 MB.

Video Content Quality Reviewer

Staffing Solutions Organization LLC (SSO)

Staffing Solutions Organization LLC (SSO), an affiliate of Public Consulting Group LLC (PCG), is focused on delighting clients with world-class managed staffing and talent consulting services. SSO is committed to a diverse workforce, which is a reflection of our clients and the people they serve.
<br><br>
Nurse Reviewer – Illinois
<br><b>Location:</b> Remote with on site visits across Illinois
<br><br>
Position Overview
<br>The Nurse Reviewer conducts provider compliance reviews to ensure adherence to state regulations, quality standards, and program requirements. This role includes conducting onsite visits, evaluating documentation, and determining provider compliance. The Nurse Reviewer works independently, exercises sound judgment, and provides recommendations that guide provider improvement and support statewide oversight efforts.
<br><br>
Duties & Responsibilities
<br><ul>
<li>Build and maintain effective relationships with providers and users to support high quality customer service.</li>
<li>Evaluate providers for compliance with applicable state and program regulations.</li>
<li>Coordinate and schedule on site provider visits; clearly communicate visit requirements.</li>
<li>Conduct compliance interviews with providers and gather all necessary information.</li>
<li>Review provider documentation, policies, and business practices for regulatory alignment.</li>
<li>Collect, organize, and submit documentation supporting compliance findings.</li>
<li>Utilize technology and web based systems to convert paper documentation to electronic format.</li>
<li>Conduct in person assessments of provider sites to evaluate compliance with oversight requirements.</li>
<li>Summarize on site visit findings accurately and professionally.</li>
<li>Exercise independent judgment to evaluate compliance and make final determinations based on documented evidence.</li>
<li>Identify deficiencies and recommend appropriate next steps to support provider improvement.</li>
<li>Analyze trends in non compliance and identify gaps in provider business processes.</li>
<li>Provide timely recommendations and updates to the Supervisor.</li>
<li>Maintain HIPAA standards and confidentiality at all times.</li>
<li>Perform other duties as assigned.</li>
</ul>
Required Skills
<br><ul>
<li>Strong interpersonal skills with the ability to relate well to staff and providers.</li>
<li>Active listening and effective communication skills.</li>
<li>Proficiency in MS Word, Excel, Outlook, and web based applications.</li>
<li>Process oriented and results driven work approach.</li>
<li>Ability to foster teamwork and collaborate across levels of management and staff.</li>
<li>Ability to work independently and within a team environment.</li>
<li>Excellent written and verbal communication skills and customer service techniques.</li>
<li>High accuracy, strong attention to detail, and commitment to quality.</li>
<li>Proven ability to meet deadlines and follow strict standards.</li>
<li>Ability to travel regularly to provider sites across Illinois.</li>
</ul>
Qualifications
<br>Education
<br><ul>
<li>Bachelor’s degree in any field (Nursing preferred)</li>
</ul>
Experience
<br><ul>
<li>Minimum 2 years of clinical experience working with critical care providers, public health providers, or providers serving children, older adults, individuals with traumatic brain injury, or individuals with developmental disabilities.</li>
<li>Minimum 1 year of experience conducting quality assurance reviews.</li>
</ul>
Certification
<br><ul>
<li>Active Illinois Registered Professional Nurse (RN) license required.</li>
</ul>
Working Conditions
<br><ul>
<li>Remote work with 2–3 on site provider visits per week throughout the state of Illinois.</li>
</ul>
Benefits (Through SSO)
<br>SSO offers a competitive benefits package that supports your health, financial well being, and long term growth, including:
<br><ul>
<li>Medical, dental, and vision insurance</li>
<li>401(k) with discretionary employer match</li>
<li>Paid time off and holidays</li>
<li>Flexible spending accounts</li>
<li>Additional employee perks</li>
</ul>
Keyword Search Terms
<br>Nurse Reviewer, RN Reviewer, Provider Management Specialist, Compliance Nurse, Healthcare Quality Review, Provider Compliance, Medicaid Compliance, Clinical Reviewer, Illinois RN, Site Visit Nurse, Healthcare Auditor, Public Health Nursing, QA Nurse, Provider Monitoring.
<br><br>
Compensation for roles at Staffing Solutions Organization LLC (SSO) varies depending on a wide array of factors including, but not limited to, the specific office location, role, skill set, and level of experience. As required by applicable law, SSO provides a reasonable range of compensation for this role. In addition, SSO provides a range of benefits for this role.
<br><br>
Applicants must be authorized to work in the U.S. This position is not eligible for work authorization sponsorship (including H-1B sponsorship) by SSO and under the federal laws relating to the F-1 STEM EAD program, this position is not eligible to support a STEM EAD extension application.
<br><br>
All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, marital status, age, national origin, protected veteran status, or disability. Staffing Solutions Organization LLC is an E-Verify participant.

Nurse Reviewer

MeshSquare

<p>We are seeking a <b>detail-oriented Data Verifier</b> to review, validate, and ensure the accuracy of data received from internal teams, and external sources. The role requires strong attention to detail, consistency, and the ability to work with confidential information while meeting deadlines.</p><p><b>Key Responsibilities</b></p><ul><li>Verify and validate data for <b>accuracy, completeness, and consistency</b></li><li>Cross-check information with <b>source documents, systems, and databases</b></li><li>Identify errors, discrepancies, or missing information</li><li>Update, correct, and maintain records required</li><li>Coordinate with relevant departments to resolve data-related issues</li><li>Maintain proper documentation</li><li>Ensure compliance with company policies and data confidentiality standards</li><li>Meet daily and monthly verification targets with high accuracy</li></ul><p>&middot; Good communication and coordination skills</p><p>&middot; Ability to work under deadlines and handle repetitive tasks</p><p><b>Perks &amp; Benefits:</b></p><p>Paid Leaves</p><p>HR Bonus</p><p>Inflation Bonus</p><p>Promotion</p><p>Increments</p><p>Medical Coverage</p><p>Leave Encashment</p><p>Contributing Saving Plan (CSP)</p><p>Saturday and Sunday Off</p><p>Complementary Food (Dinner) &amp; Tea/Green Tea (Two times)<br/><b>Office Timings: 5:30 PM - 2:30 AM</b></p><p><b>Job Type: Full-time</b></p><p>Job Type: Full-time</p><p>Work Location: In person</p>

Data Verifier

Maryland Department of Transportation

<p></p><div><div><div><div><b>(Open Recruitment)</b></div><div><b>
State Highway Administration</b></div><div><b>
Access Management Project Reviewer (Transportation Engineer IV)</b></div><div><b>
 Grade 18 (0516) SP# 26-84-04</b></div><div><b><br>
 YOU MUST APPLY ONLINE TO BE CONSIDERED FOR THIS POSITION</b></div><div><b>
http://www.governmentjobs.com/careers/mdotmd</b></div><div></div><div><br>
The State Highway Administration's (SHA) <b>District 4 (Baltimore County)</b> is currently recruiting for an <b>Access Management Project Reviewer (Transportation Engineer IV) </b>position. This position is <b>open to anyone who meets the minimum qualifications </b>listed below. The resulting list of eligible candidates will be used to fill this vacancy and may be used to fill future vacancies in this classification.</div><div><br>
<b>Nature of Work</b><b>: </b>The primary purpose of this position is to represent State Highway Administration (SHA) in District 4 as a Project Reviewer in the Access Management Section through interface and coordination with federal, state, county, and municipal agencies as well as citizens, developers, and consulting engineers. This position works directly for the Regional Engineer and assists the Regional Engineer in the review of development project documents, preparation of comments related to the district, and, under the supervision of the Regional Engineer, negotiates the application of requirements for access and highway related improvements, providing technical direction and consultant engineer coordination of SHA requirements. The primary purpose of this position is to enforce the regulations stipulated in the Annotated Code of Maryland. The Project Reviewer has the authority to recommend to the Regional Engineer that immediate corrective action is necessary. Under the direction of the Regional Engineer, the Project Reviewer will coordinate as necessary with appropriate parties to withhold the issuance of a SHA approval of a development submission and/or the access permit in the review of subdivision plans, site development plans, grading plans, and building permits through the County Review and SHA development review processes for all assigned projects.</div><div></div><i><br>
MDOT offers a generous and competitive benefits package. You can learn about our amazing benefits here</i><b><i>: </i></b><b><i>MDOT Benefits Guide</i></b><br>
<br>
<i>&ldquo;The State Highway Administration (SHA) has been named a Training magazine Training Awards winner for the seventh consecutive year.&quot;</i></div><p></p>
<div><h2 class="jobSectionHeader"><b>Qualifications</b></h2></div>
<p></p><div><p><b>MINIMUM QUALIFICATIONS:</b></p><p><b>
Education</b>: Possession of a bachelor's degree in engineering from an accredited college or university.<br>
<br>
<b>Experience</b>: Four (4) years of experience in professional engineering.</p><div><b>
Selective Qualification: </b>Two (2) years of the required experience must have involved traffic engineering, highway design, land development, access management, or<b> </b>construction project engineer experience.<br>
<br>
<ul><li><b>This statement contains a selective qualification, which is more focused in scope than the minimum qualifications for this classification. Selective qualifications are utilized when the position requires specific or additional bona fide occupational qualifications (i.e., knowledge, skill or ability).</b></li></ul></div><p><b>
Preferred Qualifications:</b></p><p><i>
The ideal candidate should possess the following:</i></p><div><ul><li>
Ability to negotiate with parties outside of state government; facilitate agreements between parties that have differences between them.</li><li>
Good computer skills and knowledge of Microsoft Office programs (e.g., Word, Excel, Access and PowerPoint) are desirable.</li><li>
Working knowledge of AASHTO (American Association of State Highway and Transportation Officials) guidelines.</li><li>
Working knowledge of Standards and Specifications for Highway Design and Construction.</li><li>
Working knowledge of Traffic Engineering principles.</li><li>
Excellent written and oral communication skills.</li><li>
Knowledge in preparing technical reports.</li><li>
Possession of an Engineer-in-Training License from the Maryland Department of Labor, Licensing, and Regulation</li></ul></div><div><br>
<b>Notes:</b><br>
<br>
1. Additional work experience in professional engineering, or in technical engineering at the journey level or above, may be substituted on a year for year basis for the required education.<br>
<br>
2. Possession of a master's degree in engineering may be substituted for one year of the required experience.</div><br>
<div></div>
3. Persons currently registered as Professional Engineers in the State of Maryland, or in a state with comparable requirements, are considered to have met the education requirements.</div><p></p>
<div><h2 class="jobSectionHeader"><b>Licenses &amp; Certifications</b></h2></div>
<p></p><div><div>Candidate must possess a motor vehicle operator's license valid in the state of Maryland.</div></div></div></div><p></p>

Access Management Project Reviewer (Transportation Engineer IV)

GRANULES

<div>Description:<p><br>
<br>
<b>Analytical QA Associate </b>is responsible of providing analytical data review of QA Documents, support the development to ensure compliance with cGMP, FDA, Internal Policies, Procedures and Specifications. Responsible for the safe and efficient execution of job duties.<b>Principle Accountabilities</b></p><h5 class="jobSectionHeader"><b><i>
JOB DUTIES &amp; RESPONSIBILITIES</i></b></h5><ul><li>
Part of analytical data review team according to the priorities.</li><li>
Perform Data Review of Raw Material, Finished Product, Packaging Materials, In-Process, Finished Product, outside testing data, water testing data, Stability Samples, cleaning validation, swab analysis, equipment calibrations, IQ, OQ, PQ, Method Validations, Verifications of Drug Substance and Drug Product and cleaning methods (Electronic data, Notebooks, logbooks, Reports, and electronic sign off's) and notify Laboratory management or designee for any deviations, Out of Trend, extraneous peaks or out of specification result</li><li>
Perform product review for analytical data.</li><li>
Responsible for ensuring and performing Data review of Analytical R&amp;D, FDA deficiencies, PDR reports, ANDA submission data related to analytical area.</li><li>
Ensure logbook is up to date of all instruments in quality control or analytical laboratory.</li><li>
Standard and accurate usage logbooks (USP, In-house, secondary, any other pharmacopoeia) and column logbooks.</li><li>
Review the data to comply with Laboratory Procedures, Test method, Protocols, GLP, GDP and cGMP and work with Laboratory personnel for any corrections and promote cGMP culture.</li><li>
Responsible to ensure the documentation is completed, any discrepancy found during the review shall be corrected before data sign-off.</li><li>
Any additional activity as assigned by the Supervisor.</li></ul><p><b>
Management Responsibility Reports to</b>AQA Manager/Associate Manager <b>Internal/External Contacts</b>NA<b>Knowledge &amp; Skills</b></p><ul><li>
Knowledge of 21CFR, ICH, USP and other applicable regulatory requirements and standards.</li><li>
Manage and host Regulatory inspections.</li><li>
Ability to maintain integrity and honesty at all times.</li><li>
Ability to communicate and lead with transparency.</li><li>
Lead department for optimal performance and set course for future improvements.</li><li>
Accountable for performance and results of department.</li></ul><p><b>
Experience &amp; Education</b></p><ul><li>
Requires minimum BA/BS in Pharmacy, Biochemistry, Chemistry or related field with 3+ years of experience in the biotech or pharmaceutical industry. Management experience in Quality Control required and MS/MA preferable.</li></ul><p><b>
Physical Requirements/Working Environment</b>NA<b>Travel </b>Minimal<b>Disclaimer</b>The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.</p>
Requirements:
<p><b>
Required Qualifications:</b></p><ul><li>
Quality assurance within Pharmaceutical Industry: 2 years highly preferred</li><li>
Manufacturing: 2 years (Preferred)</li><li>
Document management: 2 years (Preferred)</li></ul><p><b>
Knowledge &amp; Skills</b></p><ul><li>
cGMP compliance within the pharmaceutical manufacturing industry.</li><li>
Writing and maintaining cGMP documentation.</li><li>
Analyze data/information and resolve complex issues.</li><li>
Verbal and written communication skills.</li><li>
Work and communicate with cross-functional teams.</li><li>
Multiple priorities and re-prioritize tasks.</li></ul><p><b>
Experience &amp; Education</b></p><ul><li>
At least 2 -3 years of experience in a quality assurance role in a cGMP-regulated environment.</li><li>
A college Degree preferably in sciences (i.e., Biology, Chemistry etc.), or related discipline</li></ul></div>

Analytical Quality Assurance Associate/ Bio Chemist

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