Compliance Investigation Specialist I

Role Responsibilities

• Completes and facilitates completion of Manufacturing Investigation efforts within SPM to ensure compliance with quality and cycle time standards.
• Provides guidance, coaching and feedback to all groups involved in initiating, completing and conducting manufacturing investigations and CAPA analysis.
• Gathers and analyzes historical data to identify trends and root-cause of manufacturing deviations.
• Develops and recommends corrective and preventive actions to prevent/eliminate recurrent discrepancies and leads its implementation in manufacturing.
• Ensures that QAR system requirements M1/PHP are being executed as established in the site’s Standard Operating Procedures (SOP) and other guidelines.
• Acts as the primary contact in the resolution of conflicts and differences resulting from the resolution of MIRs.
• Collaborates in the design and deployment of trainings to educate employees on how to report, initiate, conduct and close an investigation.
• Leads efforts to educate leaders and employees on OPEX methods, practices and tools.
• Leads process improvement initiatives that increase quality/compliance, efficiency and safety within the Sterile Product Manufacturing facility

Basic Qualifications

• Education: Minimum of nine years of applicable experience and a BA/BS/MS degree in Engineering, Chemistry, Physical/Biological Sciences, Business, Integrated Supply Management, or related applicable discipline.
• Experience: Effective team building skills, proven leadership and change management abilities, ability to effectively coach and mentor colleagues, strong oral and written communication skills, ability to influence at all levels of the site.
• M1 and PHP education and experience, Lean Six Sigma education and experience, strong background in GMP Manufacturing, QA/QC, Aseptic Manufacturing and/or Environmental Monitoring.

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