Sr. QA Associate Specialist at Millipore Corporation in St. Louis, Missouri

Job Description:

Work Location: St. Louis, Missouri
Shift:
Department: LS-SC-PMLQ4A Quality Assurance Dekalb
Recruiter: Guadalupe Barragan


Hiring Manager: Amanda Anne 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.


• Improve quality systems in ISO production environments.
• Documentation control activities include management of the electronic documentation management system, and the ability to write, review or approve Operation Procedures, Specifications, Master Manufacturing & Packaging Procedures and other controlled documents.
• Training Management coordination including metric reporting and management of the electronic training platform.


• Complete a high volume of work to meet department goals.
• Communicate with coworkers and interact with other departments on a regular basis.
• Complete and have accurate work consistently with quality guidelines.
• Assist in maintaining department KPIs through on time CAPAs, Deviations, Complaints and Change Controls.
• Assist in compliance with Life Science and site quality policies and procedures.
• Assist and/or act as Lead Auditor in conduction internal audits.
• Assist in the investigation of customer complaints.
• Contribute to Root Cause Investigations & Effectiveness Checks of Nonconforming Incidents.
• Conduct Quality System Training specific to job function.


- This individual will work with various internal departments to develop, improve, and execute processes used in an ISO 9001 and ISO 13485 quality system environment.



ADDITIONAL LOCAL NEEDS:



• 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:



• Bachelor's degree in Life Sciences, Chemistry, Pharmacy, Chemical or Process Engineering


• 0-2 +years' experience in industry.


OR


• An Associate degree


• 5+ years experience in a QA job function as deemed appropriate by QA Management, or 5+ years' industry experience with a degree not specified in a Life Science.



Preferred Qualifications:



• Knowledge of ISO 9001 required.
• 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.


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.