Quality Assurance Chemist

Job Description

The Quality Assurance Specialist is responsible for supporting the 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 candidate must thrive in a fast-paced environment and be a self-starter. Although work primarily occurs during normal business hours, Monday to Friday, there may be instances where overtime or weekend work is necessary 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 Out of Specification (OOS), deviations, nonconformance, and investigations as required.
• Coordinate Corrective and Preventive Actions (CAPA), OOS, deviations, nonconformance, and investigations.
• Ensure systems comply with current Standard Operating Procedures (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 Good Manufacturing Practice (GMP) training and SOP training.
• Generate, publish, and manage quality systems metrics to drive continuous improvement.
• Scan and archive GMP documents.
• Perform Quality Management System (QMS) related functions including calibration tracking, product release, etc.
• Assist Environmental and Safety as necessary.

Essential Skills

• Bachelor's degree in a scientific discipline or equivalent experience.
• At least 2 years of experience in cGMP/FDA environment and ISO 9001 within relevant Quality Assurance/Compliance functions.
• Strong history in ISO 9001-2015, 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).
• Strong project, time management, and conflict resolution skills.
• Exceptional written and verbal communication skills.

Additional Skills & Qualifications

• Training experience is a plus.
• Proficient with Microsoft Office tools, especially Excel.
• Experience with QT9 is a plus.

Work Environment

This position operates in a manufacturing setting and professional office environment. The role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. Some tasks require exposure to loud noises or fumes in the plant facility, and collaboration with officials, plant managers, and employees. Physical demands include occasional sitting, climbing, balancing, stooping, kneeling, crouching, or crawling. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move 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 Jul 24, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email ... for other accommodation options.