Description:
\t\t\t\t\tQuality Assurance Specialist – Quality Systems, supports all quality system elements to assure compliance with FDA cGMP and other quality standards, with primary responsibilities in Regulatory submission review, Annual Product Review, Supplier Quality and external auditing. Provide quality oversight for regulatory submissions/updates.Final review of Annual Product Review (APR) before submission.Oversight of external and supplier quality functions including qualifying new suppliers, auditing new and existing suppliers, and maintaining compliance for quality agreements.Support of the Change Control Process specifically for supplier changes.Support Supplier Qualification Program.Support updates to the Approved Vendor/Supplier list..Perform Internal and External Audits per annual audit schedulesMay also participate in other Quality Systems responsibilities including: Tracking and Trending of Quality Data, Training, supporting site Data Integrity requirements, etc.Support site Data Integrity requirements.Provide metrics for Quality Review Board, as requested.Provide support during HACCP, FDA and other inspections.
\t\t\t\t\tSkills:
\t\t\t\t\tQuality assurance, Annual product review, label, change control, Gmp, Fda, quality systems management, pharmaceutical, Audit
\t\t\t\t\tTop Skills Details:
\t\t\t\t\tQuality assurance,Annual product review,label,change control,Gmp
\t\t\t\t\tAdditional Skills & Qualifications:
\t\t\t\t\tBachelor’s degree strongly preferred; Degree in Biology, Chemistry or related field of study preferred3 – 5 years of experience in a FDA regulated pharmaceutical facility preferred3 – 5 years of experience in Quality Assurance / Quality SystemsMust have exposure and experience with one of the primary areas of responsibility (Regulatory review, APR review, External/Supplier Quality)
\t\t\t\t\tExperience Level:
\t\t\t\t\tIntermediate Level
About ActalentActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & InclusionAt 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 peopleThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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