Job Description

Job Summary: The Quality Assurance Analyst will be responsible for coordinating the quality assurance and quality control functions of the laboratory. This individual will work with the QA Director to implement quality programs and make necessary updates to maintain compliance with corporate quality programs and lab accreditation, where applicable.

Key Responsibilities:

• Review raw data and associated analytical reports for accuracy and compliance.
• Perform daily verification of Chemistry and Microbiology balances.
• Oversight of DEA sample receipt from Clients, Controlled Substance program management, and coordination of disposal process.
• Perform review/approval of Deviations, OOS Investigations, Corrective/Preventive Action (CAPA) proposals, and other requests as assigned.
• Revise procedures relevant to job description and expertise.
• Participate in training of quality, laboratory, and administrative staff as needed.
• Perform all duties following current SOPs.
• Practice proper cGDP.
• Other duties as required.

Qualifications:

• Bachelor's degree in chemistry with 1-3 years of relevant laboratory/pharmaceutical industry experience.
• Familiarity with electronic Document Control system (e.g., CompliantPro) preferred.
• Knowledge of documentation functions within a cGMP or ISO regulated environment.
• Good communication and organizational skills.

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