Senior Specialist Quality Assurance – 37034 Position Available In Durham, North Carolina
Tallo's Job Summary: The Senior Specialist Quality Assurance - 37034 position requires a BS in Biology, Microbiology, Pharmacy, Chemistry, or Chemical Engineering, along with at least 5 years of pharmaceutical industry experience. Responsibilities include reviewing and approving qualification documents for sterile manufacturing equipment, providing QA support, and collaborating with cross-functional teams to ensure GMP compliance. Paid sick days, 401k, and discounted health insurance are included in the benefits package. The role involves overseeing documentation for various sterile equipment and supporting qualification steps for sterile equipment in a new facility. Freyr Solutions is hiring for this 12-month position, with a Monday to Friday shift from 8:00 AM to 5:00 PM. Contact Vinay Shastri at vinay.shastri@freyrsolutions.com for more information.
Job Description
Job Description:
Position Details:
Do you have the following skills, experience and drive to succeedin 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, ChemicalEngineering (or equivalent) At least 5 years of pharmaceutical industry experience 3+ years of experience with
URS, FAT, IQ, OQ, PQ
for manufacturingequipment and systems
Required Skills:
Working knowledge of sterile manufacturing and regulatoryexpectations Experience in QA oversight of sterile process validation or techtransfer Strong attention to detail, equipment qualification experience, andteam communication skills
Responsibilities:
Review and approve qualification documents for sterilemanufacturing equipment Provide QA support including document review (URS, IQ/OQ/PQ, riskassessments, batch records, etc.) Collaborate with cross-functional teams to ensure GMP complianceduring tech transfer and site qualification Support pre-approval inspection readiness and qualification of newfacilities 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. QAreview/approval of operations documentation. Role involvesoversight of a new facility under qualification for an existingvaccine. 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
