Senior Quality Assurance Specialist

Work Location: St. Louis, Missouri
Shift: No
Department: LS-SC-UYKQA1 Cherokee Quality Assurance Group 3
Recruiter: Ashley Hennessy

Hiring Manager: Darren Fields
This information is for internals only. Please do not share outside of the organization.

Your Role :

At MilliporeSigma, the Senior Quality Assurance Specialist will have a science related background with a solid understanding of cGMP guidelines as they pertain to API pharmaceutical manufacturing, with an emphasis on Quality Management Systems.

This position will be responsible for:

• Management of multiple quality system processes including, but not limited to, change control, deviation/CAPA management, and internal auditing.
• Review of data, documents, and other quality records for compliance in meeting product, system, and regulatory requirements; specifically in the area of facility, process, equipment, and computer systems validation.
• Working with appropriate internal and external stakeholders to identify and resolve quality risks, problems, or concerns.
• Understand and comply with ethical, legal, and regulatory requirements applicable to our business.
• Work cross-functionally to make improvements to the Quality System and ensure compliance with Policies & Regulatory Guidelines, including Design Control, CAPA, Nonconformance Systems, Process Controls, Management Controls and other QMS sub-systems.
• Represent QA to customers, internal stakeholders and other site projects as assigned.
• Work with QA and/or other process or business leaders on urgent/critical activities or corrective actions needed for the business.
• Support and training on Quality Management Systems as needed.

Who You Are

Minimum Qualifications:

• Bachelor's Degree in Science (Chemistry, Pharmacy, etc.) or Engineering (Chemical, Process, etc.).
• 5+ years of quality experience in a biologic, GMP, or Active Pharmaceutical Ingredient manufacturing environment.

Preferred Qualifications :

• Good working knowledge of associated industry and regulatory guidance documents; FDA guidelines, ISO standards, ICH Q7, 21 CFR Part 210 and 211.
• Experience with data integrity program as it applies to cGMP's.
• Experience in Technical review of documents pertaining to various GxP systems.
• Independent, self-starter with proven results in QA processes/Systems.
• Good working knowledge of cGMP and regulatory standards as they pertain to Drug Product and/ or Drug Substance manufacturing.
• Experience with data integrity program as it applies to cGMP's.
• Ability to work and communicate well with other key groups to achieve improvement and operational results.
• Demonstrated knowledge and experience in various computer skills, including Windows, Word for Windows, Excel, and Outlook, as well as familiarity working in a window-based environment.
• Demonstrated experience in detailed review work and following procedures, especially in a GMP regulated industry.
• Good evaluation and analytic skills for problem identification and communication to others.
• Good oral and written communication skills.
• Investigational and Root Cause Analysis skills.

RSREMD

• Pay Range for this position: $62,600.00- $93,900.00.
• The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here .

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.