What are the responsibilities and job description for the Quality Specialist position at W. R. Grace & Co.?
Job Description
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.
The Quality Assurance Specialist is on-site in South Haven, MI and reports to the Quality Assurance Supervisor.
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.
Required Qualifications
- Bachelor’s degree or equivalent experience.
- 5 years of experience in a batch pharmaceutical environment.
- cGMP experience.
Physical Requirements
- Must be able to stand, walk, sit, during working hours. Occasionally climb, balance, stoop, kneel, crouch, crawl, and climb stairs.
- Must be willing to wear PPE (Personal Protective equipment) including but not limited to hard hat, protective eyewear, steel-toed boots, hearing protection during plant visits.
Preferred Qualifications
- Experience working in cross functional teams.
- Quality experience in a contract development and manufacturing organization (CDMO) environment.
Benefits
- Medical, Dental, Vision Insurance
- Life Insurance and Disability
- Grace Wellness Program
- Flexible Workplace
- Retirement Plans
- 401(k) Company Match
- Paid Vacation and Holidays
- Parental Leave
- Tuition Reimbursement
- Company Donation Match Program
- Site specific contribution to local Wellness Center
- https://grace.com/people-and-careers/benefits/us-employee-benefits-summary/
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.
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