QA Analyst II

Piper Health & Sciences is seeking a QA Analyst II to support the 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 Analyst II 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 Analyst II include:

·       2+ 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 Analyst II includes:

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

·       Full Benefits: Medical, Dental, Vision, 401k, PTO, Paid Holidays, STD, LTD

Quality assurance, qa analyst, qa auditor, quality assurance auditor, internal audit, external audit, cgmp, good manufacturing practices, 21 cfr, quality metrics, batch record, SOP review, capa, corrective and preventative actions, change controls, supplier change, quality systems, quality operations, quality ops, biopharmaceutical, biotechnology, pharmaceutical, life sciences

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