Quality Assurance Specialist

Our client is a leading global chemical group, specializing in performance additives and solutions for water treatment & lubricants, oil & gas and plastics, flame retardants and boasts a wide product range able to fulfil the requirements of the most demanding applications, including personal care.

Located in Ashtabula, OH

Schedule: M-F 1st shift (8a-4:30p), Hybrid (3 days in/2 days out of office)

Pay: $65k-$75k

Type: Direct Hire

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

Requirements:

• Bachelors’ degree in a scientific discipline or equivalent experience.
• At least 2 years’ experience in cGMP/FDA environment (preferred).
• 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.

Responsibilities:

• The generation, review, facilitation of corrections, and archival of documents used to support GMP 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 following 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.