Quality Assurance Chemist

Quality Assurance Chemist

The Quality Assurance Specialist is responsible for supporting quality system processes and maintaining quality assurance standards, processes, and controls. This role involves close collaboration with Manufacturing, Quality Control, Maintenance, Shipping, and Receiving departments. The position requires the ability to perform in a fast-paced environment and demands a self-starter attitude. While the standard working hours are Monday through Friday, there may be a need for overtime on weekends and/or holidays to support Manufacturing and Lot Release activities.

Responsibilities:

• Generate, review, facilitate corrections, and archive 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 investigations as required.
• Coordinate CAPA, OOS, deviations, nonconformance, and investigations.
• Ensure systems are in compliance with current SOPs.
• Assist and perform investigations to resolve potential product quality issues.
• Assist with writing, revising, and approving standard operating procedures and work instructions.
• Review and approve SOPs, 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.
• Scan and archive GMP documents.
• Conduct QMS related functions including calibration tracking and product release.
• Assist Environmental and Safety functions as necessary.

Essential Skills:

• Bachelor's degree in a scientific discipline or equivalent experience.
• At least 2 years' experience in a cGMP/FDA environment and ISO 9001 within relevant Quality Assurance/Compliance functions.
• Strong knowledge in ISO 9001-2015, cGMP, CFR 210/211, FDA, Pharmaceutical, HACCP, Food Safety Management, and ICHQ7 requirements.
• Knowledge of statistical process control (SPC).
• Strong project, time management, and conflict resolution skills.
• Proficient with Microsoft Office tools, especially Excel.
• Excellent written and verbal communication skills.

Additional Skills & Qualifications:

• Experience in a manufacturing environment, with a strong preference towards chemical manufacturing/processing.
• Training experience is a plus.
• Experience with QT9 is a plus.

Work Environment:

This position operates in a manufacturing setting and professional office environment, utilizing standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. Some work requires exposure to loud noises or fumes in the plant facility, collaborating with officials, plant managers, and employees. Physical demands include occasionally sitting, climbing, balancing, stooping, kneeling, crouching, or crawling, and frequently lifting/moving up to 10 pounds and occasionally up to 25 pounds.

Pay and Benefits:

The pay range for this position is $60000.00 - $72000.00/yr. Medical, Dental, Vision, Life/AD&D, 401K, and vacation.

Workplace Type:

This is a fully onsite position in Ashtabula, OH.

Application Deadline:

This position is anticipated to close on Sep 17, 2025.