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.