Manager, Quality Control Lab Services
Millipore Corporation

Work Location: Indianapolis, Indiana
Shift: No
Department: LS-SC-POEQA3 Indianapolis QC Support
Recruiter: Katherine Hall

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

Your Role:

Responsible for managing Quality Control lab services supporting the laboratory and external clients. Internal services include QC training program, QC method transfer and stability program, QC data review, QC system Admin support, and management of internal QC projects. External support includes managing projects for clinical and commercial drug products and providing technical communication to clients regarding these drug products on behalf of the QC Laboratories.

• Responsible for the management and output of the QC data reviewers (Qualified Scientists), Stability Coordinator, QC Training team, and QC Systems team.
• Responsible for the management and output of the QC Validation team that performs QC method validations, transfers, and client support.
• Responsible for QC data integrity and the oversight of QC electronic data capture systems (Empower, Nugenesis, etc).
• Identify and drive operational and compliance improvements in the QC laboratory, track, and report improvement progress.
• Represent QC laboratory in a technical expert capacity on analytical and microbiological methods and laboratory investigations in communications with clients and internal Operations, QC Validation group Support, Quality Assurance and Technical Support departments.
• Lead and manage data integrity related deviations and OOS investigations within the laboratory for new development or later phase clinical drug products. Communicate with clients the status of these investigations.
• Develop, write and revise GMP documentation for method qualification protocols, raw material, in-process and finished drug product test specifications, analytical and microbiological methods, validation master plans etc. This may also include management of change controls for QC projects.
• As a part of the employee's job requirements, the employee may handle wastes including hazardous wastes.
• Responsible for Environmental, Health, and Safety compliance.
• Participate in regulatory inspections of the facility (e.g. FDA, MHRA, ANVISA) and customer inspections of the facility.

Who You Are:

Minimum Qualifications:

• Bachelors Degree in Chemistry or Microbiology.
• 7+ years of experience in quality control supporting GMP/GLP manufacturing operations.
• 4+ years of leadership experience.
• 2+ years of method validation experience.

Preferred Qualifications:

• Experience with analytical methods for a wide range of sample types (chromatographic including the various detector types, spectroscopic, physical etc).
• Experience with cGMPs and pharmaceutical QC quality systems.

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.

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