Overview
Join to apply for the Quality Assurance Supervisor role at MilliporeSigma .
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Responsibilities
- Providing expert guidance in resolving complex quality issues while ensuring compliance.
- Leading a team of 4 6 professionals responsible for management of multiple quality system processes including, but not limited to, change control, deviation/CAPA management, internal auditing, and validation support.
- Providing guidance for review of data, documents, and other quality records for compliance in meeting product, system, and regulatory requirements; specifically in the areas of facility, process, equipment, and computer systems validation.
- Working with appropriate internal and external stakeholders to identify and resolve quality risks, problems, or concerns.
- Understanding and compliance with ethical, legal, and regulatory requirements applicable to our business.
- Working 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.
- Representation of QA to customers, internal stakeholders and other site projects as assigned.
- Working with QA and/or other process or business leaders on urgent/critical activities or corrective actions needed for the business.
- Supporting and training on Quality Management Systems as needed.
Minimum Qualifications
- Bachelors Degree in any discipline
- 5+ years of quality experience in a biologic, GMP, or GMP Pharmaceutical
- 2+ years of industry leadership or management experience
- 1+ years of quality validation compliance oversight
Preferred Qualifications
- Bachelor's Degree in a scientific discipline
- 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 cGMPs.
- 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 (API) manufacturing.
- 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 windows-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
Pay and Benefits
Pay Range for this position - $94,800 - 142,200
Our ranges are derived from several sources, and largely reliant on relevant industry market data. Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors. This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.
What we offer
We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
Seniority level
- Associate
Employment type
- Full-time
Job function
- Quality Assurance and Science
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