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.