Quality Assurance Specialist

Job Description
Grace is seeking a Quality Assurance Specialist for our South Haven Site. The South Haven Site produces a portfolio of products for the specialty pharmaceutical industries, specifically Active Pharmaceutical Ingredients. 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 and products; documents for compliance to GMP, SOP and site requirements; documents results, resolves any nonconformance and 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; and makes disposition of finished product. coordinates necessary corrective actions;
Job Responsibilities

• Review and approve final product analytical data, review batch product deviations, assess 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.
• 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.

Required Qualifications

• Four year BS/BA degree
• Good communication skills with ability to present ideas
• Ability to communicate and present decisions to cross functional teams
• Good listening skills

Benefits
Link to information on Grace Benefits:
https://grace.com/people-and-careers/working-at-grace/benefits/us-employee-benefits-summary/
US

• Medical, Dental, Vision Insurance
• Life Insurance and Disability
• Grace Wellness Program
• Flexible Workplace
• Retirement Plans
• 401(k) Company Match – Dollar to dollar up to the first 6%
• Paid Vacation and Holidays
• Parental Leave (salaried only)
• Tuition Reimbursement
• Company Donation Match Program
• Site specific contribution to local Wellness Center

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.

Job Type: Full-time