Quality Assurance Associate I

Reports to: Quality Assurance Supervisor

Position Summary: The Quality Assurance Associate I is responsible for supporting the quality function by overseeing and providing continuous improvements for GMP activities, documentation and reports.

Primary Responsibilities: (will include other duties as needed)
•Review documentation for accuracy and compliance to procedures.
•Maintain quality assurance programs, processes and facilities by ensuring compliance with regulatory, internal and client requirements in the manufacture of products.
•Review and approve SOPs for quality impact and compliance.
•Review and approve item masters and product specifications.
•Perform technical and administrative review of batch and analytical data for accuracy and compliance to procedures for raw material, in-process and product release.
•Review and approve QC product testing documentation supporting batch release.
•Perform and manage exceptions, corrective and preventive actions, batch record review and lot releases.
•Participate in internal or external audits as needed.
•Provide continuous CGMP training to company employees in areas such as GMP Documentation Practices.
•Track quality metrics, CAPA, PPQE.
REQUIREMENTS
Essential Skills and Experience:
•BA/BS degree in Life Sciences
•At least 1 year related experience in a CGMP/ISO environment
•Basic understanding of applicable regulations
•Previous experience in technical review of records
•Attention to detail and good organizational skills
•Good verbal and written communication
•Knowledge of Good Manufacturing Practices applications

Nonessential Skills and Experience:
•Ability to work both independently and within a team environment