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GBA Companies

<div>Job: Sr. Validation Project Lead - Aseptic Liquid Fill Critical Utilities
Location: Richmond, VA or Baltimore, MD
Compli, LLC, a George Butler Associates&rsquo; affiliate, was founded in 2001 to provide commissioning, validation and regulatory support services to the life sciences industry.
We serve pharmaceutical and life science companies across North America. With regard to regulations and compliance, it&rsquo;s never been more important to understand the documentation and quality assurance activities as they relate to vendors, engineering, construction and contractors, which is why clients trust the Compli team.
<h3 class="jobSectionHeader">What You'll Do:</h3>
<ul><li>Support Client commissioning / validation for facility, utility, equipment and systems validation projects</li>
<li>Prepare and execute commissioning / validation lifecycle documents</li>
<li>Participate in any stage of clinical or commercial production including green field construction, facility renovation, new product development, product launch, or product/process upgrade</li>
<li>Write summary reports for validation and qualification protocols</li>
<li>Support project milestones, priorities and deadlines</li>
<li>Provide project reporting (e.g, budget, status and schedule reports)</li>
<li>Write operating procedures for technical equipment and practices and procedures</li>
<li>Perform system and process risk assessments and analyses</li>
<li>Schedule and coordinate protocol execution with other departments including manufacturing, facilities and project management</li>
<li>Develop project specific validation plans and strategy</li>
<li>Able to manage and execute multiple projects to meet client&rsquo;s priorities</li>
<li>Provide a practical approach to problem solving</li>
<li>Individuals must represent Compli at client sites and interact confidently with clients, contractors, management and peers</li>
<li>Other duties as assigned.</li>
</ul><h3 class="jobSectionHeader">What You'll Bring:</h3>
<ul><li>Must have minimum 7 years CQV experience with aseptic liquid fill critical utilities (WFI, Clean Steam, Clean Compressed Air, etc.) capital projects.</li>
<li>Bachelor&rsquo;s degree in a related life sciences or requisite industry training and experience</li>
<li>Ability to converse about scientific matters</li>
<li>Ability to work independently or in collaboration with others</li>
<li>In depth understanding and application of validation principles, concepts, practices and standards</li>
<li>Considered a Subject Matter Expert (SME) in one area of validation</li>
<li>Proficient in current Good Manufacturing Practices and other applicable regulations</li>
<li>Experienced with all pertinent industry best practices (e.g., ISPE) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report</li>
<li>Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards</li>
<li>Excellent written communication skills with emphasis in technical writing</li>
<li>Proficient in Microsoft Word, Excel, Power Point and Project
</li></ul>Travel: Local personnel preferred.
<ul><li>This role is not open to C2C staffing.</li></ul>
It&rsquo;s more than just a job&hellip;
At Compli, we are about innovative and intelligent people who want to solve problems. We&rsquo;re known for our technical excellence, but we bring so much more to the table. We strive to create remarkable solutions for a higher quality of life. And we are changing the industry by integrating the design and construction process with use of new technology.
At Compli, we are an Equal Employment Opportunity Employer promoting diversity in our workforce by including all individuals regardless of age, race, religion, color, sex, national origin, marital status, genetic information, sexual orientation, gender identity, gender expression, disability, veteran status, pregnancy status, or any other status protected by law.</div>

Sr. Validation Project Lead - Aseptic Liquid Fill Critical Utilities

<div>Job: Sr. Validation Project Lead - Medical Device
Location: Richmond, VA or Baltimore, MD
Compli, LLC, a George Butler Associates&rsquo; affiliate, was founded in 2001 to provide commissioning, validation and regulatory support services to the life sciences industry.
We serve pharmaceutical and life science companies across North America. With regard to regulations and compliance, it&rsquo;s never been more important to understand the documentation and quality assurance activities as they relate to vendors, engineering, construction and contractors, which is why clients trust the Compli team.
<h3 class="jobSectionHeader">What You'll Do:</h3>
<ul><li>Support Client commissioning / validation for facility, utility, equipment and systems validation projects</li>
<li>Prepare and execute commissioning / validation lifecycle documents</li>
<li>Participate in any stage of clinical or commercial production including green field construction, facility renovation, new product development, product launch, or product/process upgrade</li>
<li>Write summary reports for validation and qualification protocols</li>
<li>Support project milestones, priorities and deadlines</li>
<li>Provide project reporting (e.g, budget, status and schedule reports)</li>
<li>Write operating procedures for technical equipment and practices and procedures</li>
<li>Perform system and process risk assessments and analyses</li>
<li>Schedule and coordinate protocol execution with other departments including manufacturing, facilities and project management</li>
<li>Develop project specific validation plans and strategy</li>
<li>Able to manage and execute multiple projects to meet client&rsquo;s priorities</li>
<li>Provide a practical approach to problem solving</li>
<li>Individuals must represent Compli at client sites and interact confidently with clients, contractors, management and peers</li>
<li>Other duties as assigned.</li>
</ul><h3 class="jobSectionHeader">What You'll Bring:</h3>
<ul><li>Must have minimum 7 years CQV experience with aseptic liquid fill critical utilities (WFI, Clean Steam, Clean Compressed Air, etc.) capital projects.</li>
<li>Bachelor&rsquo;s degree in a related life sciences or requisite industry training and experience</li>
<li>Ability to converse about scientific matters</li>
<li>Ability to work independently or in collaboration with others</li>
<li>In depth understanding and application of validation principles, concepts, practices and standards</li>
<li>Considered a Subject Matter Expert (SME) in one area of validation</li>
<li>Proficient in current Good Manufacturing Practices and other applicable regulations</li>
<li>Experienced with all pertinent industry best practices (e.g., ISPE) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report</li>
<li>Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards</li>
<li>Excellent written communication skills with emphasis in technical writing</li>
<li>Proficient in Microsoft Word, Excel, Power Point and Project</li>
</ul>
Travel: Local personnel preferred.
<ul><li>This role is not open to C2C staffing.</li></ul>
It&rsquo;s more than just a job&hellip;
At Compli, we are about innovative and intelligent people who want to solve problems. We&rsquo;re known for our technical excellence, but we bring so much more to the table. We strive to create remarkable solutions for a higher quality of life. And we are changing the industry by integrating the design and construction process with use of new technology.
At Compli, we are an Equal Employment Opportunity Employer promoting diversity in our workforce by including all individuals regardless of age, race, religion, color, sex, national origin, marital status, genetic information, sexual orientation, gender identity, gender expression, disability, veteran status, pregnancy status, or any other status protected by law.</div>

Sr. Validation Project Lead - Medical Device

<div>Job: Administrative Assistant 2 (Part-Time)
Location: Broomfield, CO
Scope of Responsibility:
Provides administrative support to A/E staff within GBA with limited supervision. Works across multiple markets to coordinate a wide variety of administrative and operational tasks. Demonstrates strong organization, accuracy, and initiative while supporting efficient team operations. A positive, customer-focused attitude and collaborative &ldquo;can-do&rdquo; approach are essential to maintaining GBA&rsquo;s productive and professional work environment.
Supervisory Responsibilities:
<ul><li>None</li></ul>
What You'll Do:
<ul><li>Provide administrative support under moderate direction from project managers, department leaders, and principals.</li>
<li>Work with other administrative staff throughout A/E to coordinate and accomplish duties in a timely manner.</li>
<li>Perform various office management tasks including, but not limited to: Receptionist, coordinate with building management and Maintenance, oversee office supplies, oversee kitchenette supplies, ensure office equipment is maintained (printer/copier, plotter, AED, First Aid), maintain office tidiness</li>
<li>Perform various operation tasks including, but not limited to: Scheduling meetings, arranging lunches, assisting staff with registrations, travel arrangements, expense reports, planning office events and providing office event support, conference room IT support</li>
<li>Perform various project and client related tasks including but not limited to: Assisting staff with administration of CRM data, keeping client and employee information current, assisting Marketing and proposal personnel with qualifications, submittals, and proposals.</li>
<li>Serve as a remote backup to other receptionist and other administrative positions.</li>
<li>Run errands for business purposes.</li>
<li>Complete expense reports for company expenses in a timely manner.</li>
<li>Coordinate with HR regarding gifts and flowers for birthdays and funerals.</li>
<li>Assist with on-boarding new employees and interns.</li>
<li>Organize and assist the planning and/or payment for internal and external events.</li>
<li>Other duties as assigned</li>
</ul>
What You'll Bring:
<ul><li>High school diploma or equivalent AND 2+ years of relevant experience OR equivalent level of education and experience.</li>
<li>Notary Public credential preferred.</li>
</ul>
Technical Skills &amp; Abilities:
<ul><li>Ability to coordinate complex calendars and manage correspondence for multiple team members or leaders.</li>
<li>Ability to handle sensitive information with discretion and tact while representing the department and leadership professionally.</li>
<li>Advanced proficiency with Microsoft Office to create reports, presentations, etc. with accuracy and visual clarity.</li>
<li>Ability to prioritize multiple assignments, stay organized, and meet deadlines in a fast-paced environment.</li>
<li>Strong verbal and written communication skills to support clear and professional interactions.</li>
<li>Ability to schedule, coordinate, and troubleshoot virtual and in-person meetings using a variety of platforms and tools.</li>
<li>Ability to coordinate travel logistics and prepare itineraries using travel management tools.</li>
</ul>
Physical Requirements &amp; Work Environment:
<ul><li>Ability to work on computer for extended periods of time.</li>
<li>Ability to sit and/or stand for extended periods of time.</li>
</ul>
Travel:
<ul><li>Ability to travel for occasional day trips or overnight travel for training, conferences, project site &amp; field visits (5-10% max).</li>
<li>Must maintain a valid driver&rsquo;s license and an insurable driving record under the company&rsquo;s insurance carrier requirements to operate or rent vehicles for business purposes.</li>
</ul>
Compensation:
Pay: $20-$35/hr based on experience level
Join Our Team
If you&rsquo;re a motivated administrative assistant professional who takes pride in delivering safe, high-quality work, we&rsquo;d love to hear from you.
Apply today and build your future with GBA.
At GBA, we are an Equal Employment Opportunity Employer promoting diversity in our workforce by including all individuals regardless of age, race, religion, color, sex, national origin, marital status, genetic information, sexual orientation, gender identity, gender expression, disability, veteran status, pregnancy status, or any other status protected by law.</div>

Part Time Administrative Assistant 2

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Sr. Validation Project Lead - Aseptic Liquid Fill Critical Utilities

Sr. Validation Project Lead - Medical Device

Sr. Validation Project Lead - Medical Device

Sr. Validation Project Lead - Aseptic Liquid Fill Critical Utilities

Part Time Administrative Assistant 2