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