Quality Assurance Specialist 3
Millipore Corporation

Job Info

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Work Location: Lenexa, Kansas
Shift: Yes
Department: LS-SC-PMXQA Quality Assurance
Recruiter: Erin Wilson

This information is for internals only. Please do not share outside of the organization.

Your Role:

The Quality Assurance Specialist 3, Quality Systems and Product Support role is to manage the implementation and maintenance of quality systems and ensure MilliporeSigma's compliance with government regulations by coordinating with suppliers and customers to develop consistent and efficient business practices. The Quality Assurance Specialist 3 is the first point of contact for managing internal and external nonconformities. Responsibilities focus on enhancing the Lenexa Dry Powder Media manufacturing site by providing expertise in advanced problem-solving and implementing corrective and preventative actions by collaborating closely with internal team members, stakeholders, collaborators, and participating facilities.

• Review controlled documents to ensure GMP and procedural compliance
• Support all product quality-related changes to training curriculums, documents, equipment, specifications, and methods.
• Investigate nonconformities (Deviations) and manage Corrective and Preventative actions
• Preparation of confidential and proprietary documents and agreement
• Serves as an operational resource in the analysis of risk for adverse events through the root cause analysis process using performance improvement tools and methodology
• Drives expedited problem identification and resolution, provision of RCA-specific updates, and team interactions and deadlines driven by product release
• Site lead user for Quality Management System
• Support the development of project plans for specific quality system initiatives and process improvements
• Maintains current understanding of quality systems for business units including DPM (Dry Powder Media products) and applies and interprets regulations in making business decisions and risk assessments
• Utilizes project management tools and methodologies to track and communicate the status of RCA and provides regular updates to the RCA Teams, ensuring the team is informed of status updates of the root cause analysis
• Demonstrates leadership in developing and implementing quality system initiatives in areas of Operations and Product Support
• Establishes and maintains collaborative relationships within the system to foster successful root cause analysis completion
• Lead change team assessment of end-to-end impact for product, process, systems, assay/method, and equipment change controls
• Develops and manages best practices and tools for improvement, plan execution, and project management
• Ensure personnel are treated with respect and dignity with an emphasis on providing a strong avenue for communication and company values

Who You Are

Minimum Qualifications:

• Bachelor's Degree in Chemistry, Biology, or other Life Science discipline
• 6+ years of experience in Quality Assurance in a GMP environment

OR

• Bachelor's Degree in any non-Life Science discipline
• 9+ years of QA experience in a GMP or ISO environment within the pharmaceutical or healthcare industry

Preferred Qualifications:

• 6+ years of experience with quality assurance in Pharmaceutical or Biopharmaceutical with demonstrable familiarity with cGMPs, cGLP's and/or ISO requirements
• Thorough understanding of ISO 9001:2015, EXCiPACT, and GMP guidelines
• Green Belt certification
• Quality Auditor Certification
• Highly refined written and verbal communication skills
• Ability to organize tasks effectively with good time management and multi-tasking capabilities
• Ability to lead multi-functional teams & implement project initiatives
• Exceptional critical thinking skills with the propensity for making good risk-based decisions based upon a mixture of analysis, experience, and judgment promptly
• Working knowledge of computer programs such as TrackWise, SAP, and BPCS, in addition to Microsoft Office
• Consensus builder among teams and cross-functional groups with differing objectives and priorities

• Excellent interpersonal skills for interacting with many internal departments and management levels, along with customers, suppliers, and regulatory authorities

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.

This job has expired.