Senior Quality Assurance Specialist

Merck•Saint Louis, MO

13h

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.