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Manufacturing Investigation Lead Overview

The purpose of this Manufacturing Investigation Lead position is to serve as the primary writer for the Operations Group to ensure timely and accurate completion of manufacturing investigations, implementation of subsequent corrective actions, and completion of manufacturing change controls. This will be accomplished largely through conducting appropriate root-cause analyses for events and authoring investigations reports related to compounding, filling, inspection, and packaging of sterile and non-sterile pharmaceutical products.

Manufacturing Investigation Lead Responsibilities

Lead and support prompt and thorough investigations assuring that thorough root cause evaluations are performed in compliance with cGMPs and associated SOPs and ensures timely closure for each investigation as well as follow-up activities.
Work with the functional areas to identify the most probable root cause(s) and determine appropriate preventive and corrective actions.
Trend and analyze investigation data and address appropriately in cooperation and collaboration with other support functions such as Quality and Engineering.
Supports and maintains an environment that fosters communication and teamwork within the Operations Group and other departments.
Write technical documents to support operations including SOPs and batch records.
Train and mentor less qualified employees in the department. This includes but is not limited to processes, procedures in compliance with established protocols and regulatory guidelines.
Maintain current knowledge of cGMPs through appropriate training programs.
Share operational knowledge with peers, new-hires, contingency staff members, and newly-appointed operators, as needed, to maintain efficiencies and cGMP compliance.
Participate in team efforts to improve our work environment, product quality, efficiencies, and other initiatives identified as being beneficial to our business.
Discuss Investigations as required with regulatory agencies or clients ,as required

Manufacturing Investigation Lead Qualifications

Bachelor's degree with a minimum of 3 years of relevant experience in the pharmaceutical industry or additional education in project or documented investigational course work may be substituted for experience on a per year basis.
Associated topics: crime scene, detective, fingerprint, inspector, investigate, investigation, investigative, investigator

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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