Location: St. Louis, MO, 63103
Date Posted: 2025-06-12
Job Description: Work Location: St. Louis, Missouri
Shift:
Department: LS-SC-PMLQ4A Quality Assurance Dekalb
Recruiter: Guadalupe Barragan
HIring Manager: Amanda Whittington
This information is for internals only. Please do not share outside of the organization.
Your Role
The Sr. Quality Assurance Associate provides compliance oversight across the MilliporeSigma Quality Management System (QMS) in collaboration with site personnel. As a Sr. QA Associate, you are responsible for the coordination and maintenance of Quality Systems (i.e., Document Control, Record Control, Training Program Maintenance, Deviation/CAPA, Complaints, Change Control) and processes to ensure internal and external compliance and the promotion of quality practices that meet or exceed required guidelines and regulatory requirements. Responsibilities include maintenance and continuous improvement of the overall Quality Program.
- Support and improve ISO 9001 and ISO 13485 quality systems, ensuring alignment with regulatory standards.
- Manage documentation control activities, including authoring, reviewing, and approving controlled documents within the electronic documentation system.
- Coordinate training management, including tracking metrics and administering the electronic training platform.
- Assist with quality investigations, including customer complaints, root cause analysis, and effectiveness checks.
- Conduct or support internal audits, acting as lead auditor when required.
- Ensure compliance with CAPAs, deviations, complaints, and change controls, contributing to department KPI achievement.
- Deliver and support quality system training relevant to job functions and compliance needs.
- Collaborate cross-functionally to execute and continuously improve quality-related processes and meet department goals.
Physical Attributes:
- Environmental conditions: Varies depending on specific job responsibilities.
- 70-100% Office Environment, 10-30% On-the-floor QA activities/observation.
- Physical requirements: Give site tours of facilities including use of stairs.
Who You Are
Minimum Qualifications:
- Bachelors Degree in Chemistry, Biochemistry, Biology, or other Life Science discipline.
- 2 +years’ experience in QA function.
Preferred Qualifications:
- Knowledge of ISO 9001 and ISO 13485 and regulatory compliance issues (i.e., FDA, USDA, ICH, EDQM, IVDR) related to biologic derived materials, and prior experience working in a controlled/regulated environment.
- Current fine chemical industry knowledge &/or experience.
RSREMD
RSREMD
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.