Quality Assurance Analyst at Flex HR in College Park, GA

Job description

• The Quality Assurance Analyst plays a critical role in supporting Nitro's quality management system across the Quality Control Laboratory and broader manufacturing operations. This position is responsible for reviewing and approving analytical and batch documentation, verifying compliance with established procedures and specifications, and driving continuous improvement in quality processes—particularly for pharmaceutical raw materials, in-process materials, and finished products. The role also owns document control and training records within MasterControl, and supports FDA and ISO 9001 compliance through internal and external quality audits. As a key member of the Quality team, this role works cross-functionally with the laboratory, production, and customer-facing teams to ensure every batch and shipment meets Nitro's quality standards prior to release.

Responsibilities

• Quality Review & Release
• Review and approve contract and internal laboratory results for raw materials and finished products.
• Review testing status and approve pharmaceutical raw materials prior to use in production.
• Review and approve labeled raw material containers and finished product drums prior to shipment.
• Confirm and sign off on pharmaceutical production batches, verifying compliance with specifications.
• Documentation & Batch Records
• Prepare and maintain pharmaceutical batch documentation for use in manufacturing.
• Review, verify, and file completed pharmaceutical batch documentation for accuracy and completeness.
• Maintain accurate records of testing, retesting, and approval status for incoming raw materials.
• Document Control & Training
• Own document control processes within MasterControl, including creation, revision, routing, and approval of SOPs, specifications, and quality records.
• Maintain and audit employee training records to ensure completion and compliance with current procedures.
• Coordinate training assignments in MasterControl when documents are created or revised, and track completion status.
• Ensure documentation practices meet FDA requirements for OTC pharmaceutical manufacturing and ISO 9001 record-keeping standards.
• Regulatory Compliance & Audits
• Support compliance with FDA regulations applicable to OTC pharmaceutical manufacturing (21 CFR 210/211) and the site's ISO 9001 quality management system.
• Plan, lead, and conduct internal quality audits; support external and regulatory audits and inspections.
• Identify audit findings and nonconformances, and track corrective and preventive actions (CAPA) to closure.
• Support maintenance and continuous improvement of the quality management system to sustain FDA and ISO 9001 compliance.
• Laboratory & Quality Systems Oversight
• Oversee and coordinate analytical and physical testing performed in support of production batches (lacquer, acid, and topical pharmaceutical batches), including methods such as gas chromatography and HPLC.
• Coordinate sampling of pharmaceutical raw materials upon receipt.
• Manage submission and tracking of active pharmaceutical ingredient (API) testing.
• Monitor and maintain calibration schedules for laboratory instrumentation (gas chromatographs, HPLC, balances, standard thermometers, etc.), including Operational Qualification and Preventative Maintenance due dates.
• Perform and document instrument calibrations according to the analytical plan.
• Cross-Functional & Customer Support
• Prepare developmental samples for customer evaluation.
• Package finished product and developmental samples for shipping.
• Serve as a technical resource for contract laboratories, customers, and internal personnel on quality-related questions.
• Support laboratory organization, consumable inventory, and overall lab readiness.

Requirements

• Bachelor's degree in Chemistry or a related science (Biology, Biochemistry, Chemical Engineering) required.
• Minimum of 6 months of experience in an analytical laboratory or quality environment.
• Working knowledge of FDA regulations as applied to OTC pharmaceutical manufacturing (21 CFR 210/211) required.
• Working knowledge of ISO 9001 quality management system requirements required.
• Experience with document control and training record management, preferably within MasterControl or a similar electronic quality management system.
• Internal or external quality audit experience required; Lead Auditor certification (e.g., ISO 9001 Lead Auditor) strongly preferred.
• Working knowledge of analytical and organic testing methods and laboratory safety practices.
• Fluent in English.
• Strong verbal and written communication skills.
• Critical thinking and investigative skills.
• Highly organized with strong attention to detail.
• Demonstrated ability to work effectively as part of a team.

Skills

Required

• Laboratory safety practices
• Fluent in English