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Quality Specialist/Compliance Officer

Date: May 8, 2022

Location: South Haven, MI, US, 49090

Company: W. R. Grace & Co.

Requisition ID: 20278 

Built on talent, technology, and trust, Grace is a leading global supplier of catalysts and engineered materials. The company’s two industry-leading business segments—Catalysts Technologies and Materials Technologies—provide innovative products, technologies, and services that enhance the products and processes of our customers around the world. Grace employs approximately 4,300 people in over 30 countries.

Job Description

The Quality Specialist audits all aspects of Site operation, facilities, processes, products and documents for compliance to GMP, SOP and Site requirements, documents the results, resolves any nonconformance and coordinates necessary corrective actions.  Coordinates validation of all aspects of Site operation, facilities and processes for compliance to GMP, SOP, and Site requirements.  Prepares responses and Certificates of Analysis for customers.  Makes disposition of finished product by performing the following duties:

  • Review and approve final product analytical data, review batch product deviations, assessing quality impact and propose corrective/preventative actions, generate product Certificate of Analysis and perform product release.
  • Management of Change – review and approve revisions to master batch production records, analytical test methods, cleaning procedures, SOP’s, Forms, Master Plans and Equipment Modifications.
  • Review and approve Out of Specification laboratory investigations, Deviation Reports, ICARs.  #indeed
  • Review and 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 as required.
  • Conduct periodic internal audits of the facility, document the results, and coordinate the corrective actions.
  • Participate in FDA Audit as required.  #indeed     #WRGRACE

Required Skills, Expereince and Education

  • 4 year BS/BA degree required
  • cGMP experience is a plus but not required
  • Good communication skills and ability to communicate decisions to cross function teams is a must   WRGRACE

 

Grace is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Grace via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Grace. No fee will be paid in the event the candidate is hired by Grace as a result of the referral or through other means.


Nearest Major Market: Kalamazoo