Quality Assurance Specialist 1, Batch Release (Contractor)

Minimum Qualifications

• Bachelor’s degree in life sciences, engineering, quality, or a related field; or an associate degree with at least two years of relevant experience in a regulated environment. An equivalent combination of education and experience may be considered.

• Foundational understanding of cGMP requirements, controlled documentation, and data integrity principles.

• Ability to follow detailed procedures, recognize documentation errors, and escalate concerns appropriately.

• Strong attention to detail, organization, and written and verbal communication skills.

• Ability to manage routine priorities, meet deadlines, and work effectively with guidance.

• Proficiency with Microsoft Word and Excel; exposure to electronic quality or document management systems preferred.

1. 1Review routine executed manufacturing, filling, packaging, labeling, and analytical records using approved procedures and checklists.

1. 2Verify documentation for completeness, legibility, traceability, required signatures, calculations, and adherence to data integrity expectations.

1. 3Identify documentation discrepancies, communicate findings, and escalate potential compliance or release-impacting issues.

1. 4Compile batch disposition documentation and confirm required records are available for review.

1. 5Enter and maintain accurate batch review status, deficiencies, and follow-up actions in approved GMP systems and trackers.

1. 6Support follow-up on missing information, corrections, and documentation responses with Manufacturing, Quality Control, and Supply Chain.

1. 7Assist with deviation, investigation, CAPA, change control, and controlled-document activities as assigned.

1. 8Perform routine production-area observations and promptly report potential cGMP concerns.

1. 9Complete required training, maintain current knowledge of assigned procedures, and participate in continuous improvement activities.

1. 10Perform other quality-related duties as assigned.