QA Auditor

Piper Health & Sciences is seeking a QA Auditor to support cGMP quality and manufacturing operations for a mid-size biopharmaceutical company in the Columbia, MD area. This role ensures accurate and compliant release of drug products following cGMP guidelines.

Responsibilities for the QA Auditor include:

·       Review, revise, and approve of cGMP documents such as batch records, logbooks, and SOPs.

·       Initiate and monitor quality records including Deviations, Change Controls, CAPAs, and Out of Specification (OOS) results.

·       Review and approve the release of raw materials.

·       Perform QA on the floor activities such as quality observation, real-time batch record review, cleaning documentation, and addressing any issues with manufacturing.

·       Participate in internal and local external audits as needed.

·       Collaborate across quality and manufacturing departments to ensure training and quality system compliance.

·       Assist with tracking and reporting of quality metrics/KPIs.

Qualifications for the QA Auditor include:

·       3+ years of quality assurance experience within the pharmaceutical and/or biotechnology industry.

·       Proven experience operating under current Good Manufacturing Practices (cGMP).

·       Experience reviewing batch records and conducting internal audits is highly preferred.

·       Knowledge of MasterControl is preferred, but not required.

Compensation for the QA Auditor includes:

·       Salary Range: approximately $70,000 - $85,000 annually, commensurate with experience

·       Comprehensive Benefits: Medical, Dental, Vision, 401k, PTO, Paid Holidays, STD, LTD, Paid Sick leave (as required by law)

 This role is open for applications on 4/2/2025. Applications will be accepted at least 30 days from the posting date.

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