Senior Specialist Quality Assurance - 37034

Company: Freyr
Location: Durham
Posted on: May 1, 2025

Job Description:

Position Details:

Do you have the following skills, experience and drive to succeed in this role Find out below.

Job ID: 37034
Duration: 12 months
Shift: Monday to Friday, 8:00 AM - 5:00 PM
Benefits: Paid sick day, 401k, Discounted health insurance

Qualifications:

Required Education and Experience:

BS in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent)
At least 5 years of pharmaceutical industry experience
3+ years of experience with URS, FAT, IQ, OQ, PQ for manufacturing equipment and systems

Required Skills:

Working knowledge of sterile manufacturing and regulatory expectations
Experience in QA oversight of sterile process validation or tech transfer
Strong attention to detail, equipment qualification experience, and team communication skills

Responsibilities:

Review and approve qualification documents for sterile manufacturing equipment
Provide QA support including document review (URS, IQ/OQ/PQ, risk assessments, batch records, etc.)
Collaborate with cross-functional teams to ensure GMP compliance during tech transfer and site qualification
Support pre-approval inspection readiness and qualification of new facilities
Oversee documentation related to isolators, incubators, lyophilizers, fillers, and other sterile equipment

Comments/Special Instructions:

Manage multiple equipment documents including pre/post reviews. Support qualification steps for sterile equipment. QA review/approval of operations documentation. Role involves oversight of a new facility under qualification for an existing vaccine.

Regards,
Vinay Shastri
Senior Associate - Pharmaceutical Recruitment
Phone: +1 609 681 2410
Email: vinay.shastri@freyrsolutions.com
150 College Road West, Ste 102, Princeton NJ - 08540
Connect on LinkedIn
www.freyrsolutions.com

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