Sr. Investigator
Millipore Corporation

Job Info

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Work Location: Indianapolis, Indiana
Shift: No
Department: LS-SC-POEQC1 QMS
Recruiter: Leah S Westley

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

Your Role

This position is responsible for assembling all individuals required for preparing / completing timely and thorough investigations, and actively participating in the preparation/approval of investigations. Position ensures investigations are compliant with CFR,FDA and ICH Guidance, global regulatory expectations, and international cGMPs. .

Major Position Activities & Responsibilities:

• Supervise and lead site wide effort of designing, conducting, and writing investigations; provide guidance and direction to all departments regarding investigations and appropriate CAPA.
• Assemble individuals required for preparing / completing timely and thorough investigations, and actively participating in preparing investigations.
• Collaborate, in a hands on manner, and provide direction on investigations and technical issues at the Indianapolis facility and at contract manufacturing sites
• Handle/investigate product complaints.
• As needed, compile data and authors reports that are submitted to regulatory agencies in support of product licenses and applications
• Performs special projects and other duties as assigned.
• As a part of the employee's job requirements, the employee may be required to handle wastes including hazardous wastes. The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training.

Scope:

• Primary responsibility is guiding all STPS investigations, to ensure compliance with regulatory expectations, ensure thoroughness, and ensure effective CAPA are implemented.
• Functions as a key technical resource in the Quality Operations organization
• Responsible for notifying management of any quality issue that require notification of regulatory authorities, e.g. NDA Field Alert reports.
• Responsible for supporting management during regulatory inspections, e.g. providing details and rationale of STPS investigations.
• Does not have any direct reports.

Who You Are

Minimum Qualifications:

• Position requires a Bachelor's degree in biology, chemistry, pharmacy, or life sciences, and a minimum of 2 years of experience; or at least 4 years of experience in the pharmaceutical industry in a technical or quality role, with prior experience in investigations and CAPA activities.

Preferred Qualifications:

• Experience with sterile drug products and biopharmaceuticals preferred.
• Experience with FDA, and EU GMPs, and ICH Guidance
• The position requires proven ability and skill in analyzing, understanding, and presenting technical data
• Experience in technical writing and communicating across organization functions and organizational levels is expected.

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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