Looking For a Quality Assurance Specialist for a Pharmaceutical Company in Foster City,CA!

　　Description:

　　Day to Day

　　• Supporting method changes, test method reports, method validation reports, method transfers, stability protocols

　　Reviewing to know the requirements for those types of validations and protocols and understand the compliance – will review and send on to next reviewer analytical partner – they are ensuring compliance and must have analytical knowledge to understand if in compliance or not• Communication with analytical operations teams

　　• Supporting mailbox- analytical operations will send documents into mailbox and the person will need to assign the document to reviewer

　　• Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements

　　• Serves as Analytical Operation Lead for clinical and commercial projects

　　• Leads quality investigations/deviations/quality event escalation meetings, and effectively communicates and escalates major and/or critical events to upper management in a timely manner.

　　• Reviews and approves method validation and/or transfer documents including protocols, reports, methods, change controls and specifications for small molecules and/or large biologics for analytical operations, and contract labs/manufacturers across the clinical and commercial supply chains.

　　• Reviews and audits method validation related data in CMC sections of NDA / global filings.

　　Qualifications:

　　• 2-3+ years of experience in a GMP environment related field and a BS or BA.

　　• Prior experience in the pharmaceutical industry is required.

　　• Strong experience in laboratory investigations (OOS, OOT, Atypical), deviations and associated CAPAs

　　• Analytical experience - working knowledge of HPLC / chromatography

　　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.