Quality Assurance Specialist at Millipore Corporation in St. Louis, Missouri

Job Description:

Work Location: St. Louis, Missouri
Shift:
Department: LS-SC-POKQB Cherokee Quality Assurance 2
Recruiter: Michelle Matthews



This information is for internals only. Please do not share outside of the organization.




Your Role



At MilliporeSigma, the Quality Assurance Specialist at the Cherokee location in St. Louis, MO, will work with various internal departments to improve and execute processes in compliance with cGMP regulations in 21CFR 210, 211, Part 11 and in ICH Q7. Responsibilities and tasks below:

• Review raw material and batch records, as applicable, for completeness and accuracy based on GMP requirements to ensure acceptable product and process consistency.


• Release activities for raw materials and cGMP product as applicable.


• Write, review, and approve Investigations, OOS (out-of-specification), OOT (out-of-trend), CAPAs and Change Controls.


• Participate in internal/external audits as needed.

• Provide quality oversight and support for new product introductions as primary quality point of contact.


• Respond to quality-related customer questions.


• Write, review, and approve Operating Procedures, Manufacturing documents, Technical Transfer Protocols, and other controlled documents under a Quality Managed System (QMS).


• Review and approval of raw material specifications, stability study protocols and study data, master packaging formulas, master shipping records, and master manufacturing formulas as applicable.


• Document and label issuance activities.


• Review and release of manufacturing equipment post cleaning activities.


• Interact with production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.


• Monitor product for quality related issues and collaborate on resolution.


• Lead Process Improvement for Quality related initiatives/projects.


• Participate in QA on the floor activities in manufacturing, packaging, and QC areas where applicable.

Who You Are




Minimum Qualifications:

• Bachelor's Degree in Chemistry, Chemical Engineering, or other life science discipline.


• 5+ years of QA and/or QC experience.


• OR


• Master's Degree in Chemistry, Chemical Engineering, or other life science discipline.


• 2+ years QA and/or QC experience.

Preferred Qualifications:

• Knowledge of ICHQ7 and API knowledge and/or experience.

• TrackWise and SAP experience.


• Proficiency in MS Word, MS Excel, MS PowerPoint, and the ability to learn and operate other specific application software.


• Excellent communication (verbal & written) and customer interfacing skills.


• Experience writing technical documentation & reports.


• Ability to simultaneously manage multiple tasks/priorities.

• Good problem-solving, time management and negotiating skills.


• Capacity for independent work.


• Data analysis, presentation, and experimental design knowledge.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination. Apply Now