W. R. Grace · 1 day ago
Quality Assurance Specialist
South Haven, MI, US, 49090
Full-time
Onsite
Senior Level
$69K/yr - $94K/yr
5+ years expW. R. Grace is a leading global supplier of catalysts, engineered materials, and fine chemicals. The Quality Assurance Specialist will audit operations for compliance with cGMP, document results, resolve nonconformance, and coordinate corrective actions while ensuring product quality and compliance at the South Haven site.
Advanced MaterialsChemicalHardwareInnovation ManagementManufacturing
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
Qualification
Required
Bachelor's degree or equivalent experience
5+ years of experience in a batch pharmaceutical environment
cGMP experience
Must be willing to wear PPE (Personal Protective equipment) including but not limited to hard hat, protective eyewear, steel-toed boots, hearing protection, Level A suit, full face respirator
Preferred
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
Company
W. R. Grace
Grace, a Standard Industries company, is a leading global supplier of specialty chemicals and solutions that enable industries to enhance modern life.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$0.4M2021-04-26Acquired
2017-12-07Post Ipo Debt· $0.4M
1953-01-01IPO
Leadership Team
William Agne
Chief Financial Officer (CFO), Specialty Catalysts
Kerrie L. Wolfe
SVP HR and Communications, Chief Human Resources Officer
Recent News
2025-11-03
2025-10-14
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