What are the responsibilities and job description for the QA Supervisor position at Actalent?
- Coordinate and facilitate client audits and respond to their queries in an expedited manner, ensuring alignment with cGMP guidelines for cell and gene therapy manufacturing.
- Communicate audit findings to all internal stakeholders and ensure appropriate follow-up and issue resolution.
- Author, review, and approve Standard Operating Procedures for GMP related operations, including the QMS, QC laboratories, Facilities and Operations.
- Manage Deviations/OOS’s and have in depth knowledge of manufacturing and QC to be able to assess and rationalize, and perform sound investigations with robust root cause and appropriate CAPA.
- Able to identify when Change Controls are required and can implement and manage them through to completion in a timely manner.
- Onboard and manage vendors, ensuring the are approved and monitored throughout their lifecycle.
- Release and management of incoming components and materials.
- Collaborates with operational counterparts in order to train and mentor personnel to drive proactive improvements in the organization.
- Coordinate and deliver training activities to enhance GMP knowledge and skills.
- Coordinate and document training and qualifications for GMP aseptic manufacturing for operations and R&D teams.
- Conduct quality risk assessments using established techniques such as FMEA’s, and Fault Tree Analysis.
- Support creating quality systems for new GMP facilities and supportive labs specializing in cell and gene therapy manufacturing.
- Ensures the site is in a state of Inspection readiness
- Prepare Quality Control and Process Development labs policies and procedures following Good Laboratory Practice (GLP) compliance and Occupational Safety and Health Administration (OSHA guidelines).
- Actively participate as a member of the quality assurance project teams to deliver on key projects and initiatives.
- Will be overseeing 5-10 people
- 5-7 years of GMP experience and 2 years of supervising
Top Skills Details:
Quality Assurance, GMP, Batch Record Review, CAPAs
Additional Skills & Qualifications:
- B.Sc in Molecular Biology, Chemistry, Biochemistry
- At least 5 years of technical experience in a biologics manufacturing environment.
- Cell or gene therapy experience is preferred in a biotech company or CDMO.
- Significant understanding of GMP’s as they relate to drug product cell and/or gene therapy.
- Excellent written and verbal communication skills.
- Experience in QC, QA and Manufacturing is preferred
- Shop floor QA management
- Needs to be SME for the QA process
- Give final green light on deviations and NOEs
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.
Salary : $51
