Duties and Responsibilities:

The Quality Assurance Specialist is responsible for supporting the quality system processes and for maintaining quality assurance standards, processes, and controls.

The Quality Assurance Specialist collaborates closely with Manufacturing, Quality Control, Maintenance, Shipping, and Receiving. The incumbent must be able to perform in a fast-paced environment and be a self-starter. The QA Specialist is expected to work during normal business hours, Monday – Friday, but may be required to overtime or on weekends and/or holidays to support Manufacturing and Lot Release activities.

Key duties include but not limited to the following:

• The generation, review, facilitation of corrections, and archival of documents used to support Good Manufacturing Practice manufacture of Final Product.
• Perform internal and external audits as assigned.
• Review and release raw materials, intermediate products and finished products. Assist in incoming material and tote inspection.
• Perform review and approval of OOS, deviations, nonconformance, and investigation as required.
• Coordinate CAPA, OOS, deviations, nonconformance, and investigations
• Ensure systems are in compliance with current SOPs.
• Assist investigations and resolve potential product quality issues to improve efficiency.
• Assist with writing, revising, and approving standard operating procedures and work instructions.
• Review and approve SOP, protocols and reports as necessary.
• Coordinate and/or conduct GMP training and SOP training.
• Generate, publish, and manage quality systems metrics to drive continuous improvement.
• Scanning/archiving of GMP documents.
• Assist QC Lab Manager with QMS related functions including calibration, release, etc.
• Assist Environmental and Safety as necessary.
• The QA Manager may assign other duties as deemed necessary to complete the goals and objectives of the department.

General Requirements:

• Bachelors’ degree in a scientific discipline or equivalent experience.
• At least 2 years’ experience in cGMP/FDA environment (preferred) and ISO 9001 within relevant Quality Assurance/Compliance functions.
• Proficient with Microsoft Office tools, especially Excel.
• Experience with QT9 a plus.

Requirements: Skills, Qualifications, Experience, Special Physical Requirements:

• Strong background in ISO 9001-2015, ISO 14001-2015, cGMP, CFR 210/211, FDA, Pharmaceutical, HACCP, Food Safety Management and ICHQ7 requirements.
• Experience in a manufacturing environment, with a strong preference towards chemical manufacturing/processing.
• Knowledge of statistical process control (SPC) and applicable software. Knowledgeable in determining cost of quality through the use of data driven key indicators.
• Strong project, time management and conflict resolution skills.

Working Conditions:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
• The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.

Must pass Department of Homeland Security background check, pre-placement physical and pre-employment drug-screen.