Qureos Mentor

Catalent Pharma Solutions

<div>Quality Specialist I
Position Summary
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
Welcome to Greendale, Indiana! Greendale is one of two gummy technology development and manufacturing facilities in North America. The site has the capability to manufacture traditional gelatin gummies as well as 100% plant-based pectin gummies for nutritional supplements and nutraceuticals. With extensive development and manufacturing expertise and a wide range of flavors, shapes, sizes, and colors available, we can work with complex ingredients to help create engaging new products consumers will love.
The Quality Specialist I is responsible for auditing the products and processes at various points in the areas of production and packaging to ensure adherence to company quality standards. The Quality Specialist I will communicate any deviations to management &amp; assist the Quality Assurance team with special projects as required. The shift for this position will be Monday - Friday 3PM - 11:30PM. This position is 100% based onsite in Greendale, IN.
The Role<ul><li>
Conduct thorough and detailed quality audits of lines to ensure products meet established quality standards. Equipment verification including metal detector, x-ray, scales, etc.</li><li>
Audit paperwork of operators to ensure they are meeting quality standards.</li><li>
Report any deviations to QA Supervisor in complete appropriate details. Report any housekeeping issues that need attention.</li><li>
Document all areas of non-compliance and ensure corrective action to eliminate them.</li><li>
Work with Production and Packaging Managers, Supervisors, and hourly associates on daily issues and problems.</li><li>
Utilize computer to enter and track result data.</li><li>
Comply with SQF, Food Safety Plan (HACCP), Food Quality Plan (FQP) standards. Responsible for ensuring compliance to FDA and cGMP standards for Quality Control, including continuous training.</li><li>
Responsible for ensuring Dietary Supplement&rsquo;s Identity, Purity, Strength and Quality.</li><li>
Participate in all necessary training is required to successfully perform job responsibilities.</li><li>
Other duties as assigned.</li></ul>
The Candidate<ul><li>
High School Diploma or GED required. BS in Food Science or related major is preferred.</li><li>
For business and safety reasons, must be able to communicate effectively verbally and in written English. Ability to communicate with all line level positions and management.</li><li>
Knowledge of GMP and Quality systems.</li><li>
The employee must be able to lift and/or move up to 50 pounds. While performing the duties of this job, the employee is required to use hands to finger, handle, or feel and is frequently required to stand, walk, reach with hands and arms, stoop, kneel, crouch, or crawl, and talk or hear. The employee is required to sit, climb, or balance and taste or smell. The position requires a great deal of walking and standing, approximately 85%.</li></ul>
Why You Should Work At Catalent<ul><li>
Spearhead exciting and innovative projects</li><li>
Fast-paced, dynamic environment</li><li>
High visibility to members at all levels of the organization</li><li>
152 hours of PTO + 8 paid holidays</li></ul>
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. 
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written &amp; signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond&mdash; it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.</div>

Quality Specialist I

<div>Associate Scientist
Position Summary
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
The Associate Scientist is responsible for performing analytical research and development work in the Analytical R&amp;D Department. The Associate Scientist work/assist on method development, method transfer, method verification and method validation under appropriate guidance along with routine release and stability testing in support of clinical development and registration activities required for the regulatory submissions.
This is a full-time on-site salaried position, Monday - Friday 8:00am - 5:00pm
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
The Role<ul><li>
Perform technical review of client's documents as required including but not limited to specification/validation reports/test methods/compliance reports etc. to perform gap analysis with respect to methods/instruments/procedures etc. for completing methods transfers from client's/or their third-party labs with guidance from supervisors/senior team members</li><li>
Analysis of finished products, in-process materials, raw materials, according to the assigned specifications, methods, and protocols according to cGLP and cGMP. Document, process, report the data as applicable to support the team in timely fashion</li><li>
Perform analysis as required to support assigned testing using KF titrations/Dissolutions/IR/UV spectrophotometers, LC to perform dissolutions/assays/BU/CU, impurities and data processing using Empower and document per applicable test methods/specification/protocols etc. with guidance from senior team members</li><li>
Use Empower software- creating instrument/processing/report methods and performing online empower calculations for assay/dissolutions/impurities etc. Knowledge of Trackwise for managing deviations and investigations and ability to manage /handle with guidance from supervisors/senior team members</li><li>
Troubleshoot and propose any method improvement requirements during the method feasibility work of client supplied methods and/or during compendial method evaluation for assay, impurities, dissolution etc. with guidance from supervisors/senior team members. Methods and/or during compendial method evaluation for assay, impurities, dissolution etc. with guidance from supervisors/senior team members</li><li>
Perform/assist team members in method transfers, Compendial verifications or full method validations (forced degradation and calculating mass balance/peak purity to prove stability indicating nature of the method) per applicable guidances (USP &lt;1224&gt;, &lt;1225&gt;, &lt;1226&gt; ICH Q2 etc.) / SOPs with guidance from the supervisors/senior team members</li><li>
Perform stability testing on developmental/clinical/registration batches as per approved test methods/stability protocols and report/document per applicable specification/stability protocols. Escalate any OOS/OOT/atypical/trending results with supervisors or concerned team members.</li><li>
Other duties as assigned</li></ul>
The Candidate<ul><li>
Bachelor's Degree in Chemistry, Pharmaceutical Sciences or Life Sciences is required, preferred major Analytical Chemistry</li><li>
Must have at least one year of experience in pharmaceutical industry and 1+ years of experience in analytical testing/research experience using HPLC/GC/UV, etc</li><li>
Understand analytical chemistry calculations such as concentrations (Area%, %w/w, ppm, &micro;g/mL, etc.), molarity, Beer&rsquo;s Law, reference standard purity on as is, anhydrous, or dry basis etc. is required</li><li>
Basic understanding and knowledge of analytical chemistry and chromatographic techniques (e.g., LC/GC/dissolutions) and spectroscopic (e.g., UV) analysis is required</li><li>
Demonstrate Knowledge and ability to understand and follow ICH guidelines (ICH Q1, Q2, Q3 etc.) including other regulatory guidelines</li><li>
Adhere and perform all lab job duties/responsibilities according to applicable SOP's related to DEA scheduled drugs, safety, waste management and housekeeping and work with the team in improvement of the processes and procedures is required</li><li>
Assisting with other personnel with lifting of liquid containers and all objects of greater than 50 lbs. is required</li></ul>
Why You Should Join Catalent
<ul><li>Several Employee Resource Groups focusing on D&amp;I</li><li>
Tuition Reimbursement &ndash; Let us help you finish your degree or earn a new one!</li><li>
Generous 401K match</li><li>
152 hours accrued PTO + 8 paid holidays</li></ul>
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. 
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written &amp; signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond&mdash; it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.</div>

Associate Scientist

Join Catalent Pharma Solutions and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Catalent Pharma Solutions

ABOUT_COMPANY

Quality Specialist I

Associate Scientist