What are the responsibilities and job description for the Pharmaceutical Quality Assurance Specialist position at Collabera?
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.
Responsibilities:
- Assess and prepare manufacturing sites for Pre-Approval inspections by Regulatory agencies for new products.
- Independently manage project assignments reporting to the Quality Assurance Organization.
- Demonstrate strong interpersonal, communication, negotiation, and persuasion skills.
- Provide immediate project support on the review and approval of commissioning and qualification (C&Q) documents.
- Support QA activities including review and approval of GMP documentation, change management, and manufacturing/batch documents.
- Ensure project compliance with cGMP, regulations, and the Company’s Quality Management System.
- Focus on Qualification and Compliance covering Manufacturing Equipment.
Review and approve master batch records, technical protocols, investigations, change controls, SOPs, validation protocols, and technical reports. - Consult with next-level manager on complex decisions as needed.
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.
- Strong relationship building skills.
- Ability to work independently and manage project assignments effectively.
Pay Range:
$45 - $50/hr.
Salary : $45 - $50
