What are the responsibilities and job description for the QA Associate position at Actalent?
Description:
- QA Associate will support compliance over all onsite R&D activities at the site including the analytical lab, formulation development lab, and the scale-up suites. Most products are in late-stage development or clinical batches for use in clinical trials requiring strict attention to GMPs.
- Perform review of all SOPs and documentation from the labs for GMP compliance (equipment logs, calibrations, sample logs, test sheets, validation documents, OOS, etc) and production/formulation areas (equipment checks, batch, and packaging records, deviations, investigations, change controls, CAPA's, etc).
- Perform daily and weekly walkthroughs and audits of lab and production suites.
- Provide GDP training and support to R&D teams answer questions and provide mentoring and coaching as needed.
Skills:
Quality Assurance, GMP, OOS, HPLC, Data review, and Auditing
Skills & Qualifications:
- BS Degree Preferred, HS Diploma Required
- 2 years in Quality/GMP Environment with at least 2 years directly in a QA role. Pharmaceuticals are strongly preferred.
- Must have experience reviewing analytical or QC data, test packets, OOS, etc.
- Previous experience reviewing documentation listed above for compliance with GMP (the more well-rounded the better)
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 : $25 - $28