What are the responsibilities and job description for the Quality Assurance Associate position at Actalent?
Support QA Manager in cGMP manufacturing and laboratory operations through monitoring and enforcement of the Quality Management System including, but not limited to, deviations, change controls, and CAPAs.
Description:
- Review and approve Standard Operating Procedures for GMP related operations
- Support operators and support staff as needed to identify and address product quality and compliance issues as they arise
- Provide QA oversight for all BioCentriq operation processes
- Interface closely with Manufacturing, Quality Control and Process Development to assist with batch record/ data review, release, and compliance issue resolution
- The successful candidate will support Quality Control (QC) and Operations to ensure the departmental work is being completed as per company (SOPs) and regulatory (i.e. cGMP) standards.
- Assist in developing new approaches to solve problems identified during quality assurance activities.
- Assist during client and regulatory inspections/audits.
- Review/Approve related documents for batch records disposition
- Other QA duties as assigned
Additional Skills & Qualifications:
- Bachelor’s Degree in Life Sciences or Engineering
- 2 years of relevant GMP experience in biotech company or CDMO, with broad knowledge of current Good Manufacturing Practices, Quality Systems and Analytical Method development and validation
- Understanding of cGMP/ICH/FDA regulations and guidelines
- Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint)
- Experience in developing, reviewing and approving cGMP related documents (SOPs, protocols, reports, etc.)
- Detail orientation, with strong communication and organizational skills
- Capable of working with minimal supervision
- Demonstrated ability to solve problems
- Needs Pharmaceutical experience
- CDMO and/or cGMP
- Cell Therapy
Experience Level:
Entry Level
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
About Actalent
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.
