Quality Assurance Specialist

W. R. Grace & Co.•South Haven Charter Township, MI

59d•$68,683 - $94,439•Onsite

About The Position

Grace, a Standard Industries company, is a leading global supplier of catalysts, engineered materials and fine chemicals. We provide innovative products, technologies and services which our customers use to manufacture everyday products like renewable fuels, pharmaceuticals, toothpaste, cosmetics, food packaging, beer, edible oils and more. Our thousands of employees help shape a better future at our global headquarters in Columbia, MD and locations worldwide. Grace’s South Haven site produces a portfolio of products for the specialty pharmaceutical industries, specifically Active Pharmaceutical Ingredients (API). Consisting of a cGMP kilo lab, pilot plant and custom manufacturing at commercial volumes, the site is fully equipped to develop and manufacture custom drug intermediates and APIs. South Haven is nestled on the coast of Lake Michigan with beautiful beaches and fun year-round. The Quality Assurance Specialist audits all aspects of Site operation, facilities, processes, products and documents for compliance to current Good Manufacturing Practices (cGMP), SOP and Site requirements. They document the results, resolve any nonconformance and coordinates necessary corrective actions. They coordinate validation of all aspects of Site operation, facilities and processes for compliance to cGMP, SOP, and Site requirements. They also prepare responses and Certificates of Analysis for customers and make disposition of finished product.

Requirements

Bachelor’s degree or equivalent experience.
5+ years of experience in a batch pharmaceutical environment.
cGMP experience.

Nice To Haves

Experience working in cross functional teams.
Quality experience in a contract development and manufacturing organization (CDMO) environment.

Responsibilities

Ensure site compliance with cGMP (current Good Manufacturing Practices).
Approve batch product deviations, assessing quality impact and proposed corrective/preventative actions.
Approve final product analytical data.
Perform product release activities, including Certificate of Analysis generation.
Management of Change – approve revisions to master batch production records, analytical test methods, cleaning procedures, SOP’s, Forms, Master Plans and Equipment Modifications.
Approve Out of Specification laboratory investigations and Deviation Reports.
Approve validation (prospective, retrospective and concurrent) of equipment, facilities, processes and methods.
Annual Product Quality Reviews – perform and document Quality portion of the review; propose corrective/preventative actions based on the review to improve product/process control and quality compliance.
Host Customer Audits and respond to audit findings.
Conduct periodic internal Quality audits of facility areas and systems, document the results, and coordinate corrective actions.
Conduct external Quality audits of contract laboratories and raw material suppliers.
Participate in FDA Audits.