What are the responsibilities and job description for the Quality Assurance Specialist position at Collabera LLC?
Job Details
About the Role:
We are seeking a Quality Assurance professional with a minimum of a BS in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 5 years of experience in the Pharmaceutical Industry.
The ideal candidate must have a working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products, with experience in quality assurance oversight of sterile manufacturing, sterile process validation, and/or sterile process technology transfer.
Education Qualification:
Bachelor's degree in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent).
Required Skills:
Minimum 5 years of experience in the Pharmaceutical Industry.
Knowledge of regulatory expectations for sterile pharmaceutical products.
Experience in quality assurance oversight of sterile manufacturing, sterile process validation, and/or sterile process technology transfer.
3 years of experience with development, review, and approval of User Requirement (URS), FAT, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for pharmaceutical and biotechnology manufacturing equipment.
Ability to work independently and manage project assignments effectively.
The payarange is $50-$55/hr
Salary : $50 - $55