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Director, QC Microbiology

Company: NITTO DENKO Avecia, Inc
Location: Milford
Posted on: September 12, 2020

Job Description:

Career Opportunities: Director, QC Microbiology (1221) Req Id  1221  - Posted  08/19/2020  -  United States  -  Massachusetts  -  Avecia: Milford, MA  -  Quality Control  -  Regular Full Time  -  Nitto Denko Avecia Inc.

Director, QC Microbiology manages all of the QC-Microbiology related testing activities such as Environmental, Water, and release testing for API and Drug Product Facilities for Avecia sites. The position leads and supports the development, implementation, and maintenance of Quality Control (Microbiology) systems and activities for Avecia sites (MA, OH and CA).

Key Job Responsibilities:

? Execute management duties in accordance with company policies, including interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Mentor, motivate and challenge to drive high performance and develop team members, and developing staff to solve complex problems

? Ensure all staff follow site safety requirements, promote a culture of safety, whereby all accidents are preventable and support site safety initiatives.

? Direct staff to ensure timely and accurate execution of projects in full compliance with safety, budget, cGMP and other regulatory standards as required.

? Oversee sampling and testing of an ISO-8 and purified water systems manufacturing environment including training, review, reporting, and trending of data.

? Assume ownership of assigned quality documentation, such as exceptions, change controls, Environmental Excursions, and CAPAs, ensuring that documentation is initiated and closed on time, required actions are thorough and meet procedural requirements as well as customer needs.

? Present Avecia’s Microbiology Controls and Capabilities to clients. Represent as Avecia’s SME on Environmental, Water, Endotoxin, and Microbial subjects to define scope of work following Customer requests for proposal (RFP).

? Author, revise, and approve SOPs to improve efficiency and regulatory compliance and author and/or facilitate process endotoxin and microbial risk assessments based on best practices and process details.

? Ensure cross site alignment of Environmental Monitoring and Water System policies and procedures as required for API and Drug Product (Aseptic) industry.

Job Requirements:

? BS (Microbiology or Biology) with 15+ experience or MS (Microbiology or Biology) with 12+ years of experience. Additionally 5+ years of Lab Management experience is preferred.

? Advanced knowledge of Aseptic manufacturing regulations, Aseptic techniques, Clean room behaviors, and environmental monitoring operations including USP, Pharm. Eur. and other compendial methods and procedures.

? Advanced knowledge of microbiological practices, procedures, and common analyses, such as Bioburden, Microbial Limits (preparatory & screening), Sterility, Endotoxin (Gel-Clot & Kinetic Chromogenic methods), validation - Inhibition/Enhancement Sterility Test Method Validation (Bacteriostasis/Fungistasis), Preservative Efficacy Testing, and Environmental Monitoring.

? Quality Systems experience in an FDA regulated industry. Extensive knowledge of ISO-8 / ISO-14644 sampling and testing requirements. Extensive knowledge of sampling and testing of USP/EP Purified Water Systems.

Keywords: NITTO DENKO Avecia, Inc, Milford , Director, QC Microbiology, Other , Milford, Connecticut

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