Quality Program Manager, Sterility Assurance

At Proclinical, we are seeking an individual to fill the role of Quality Program Manager, Sterility Assurance, based in Seal Beach, CA. The successful candidate will be responsible for planning, coordinating and facilitating microbial control activities required for drug products. The role will interact with all site and cross site functions that could impact microbial control program including Facilities, QC Microbiology, Manufacturing, Process Sciences.

Responsibilities

• Support investigations pertaining to microbial contamination to ensure identification of effective root-cause analysis, assignment of appropriate corrective actions and determination and remediation plans.
• Partner with Manufacturing to champion company's compliance to aseptic procedures and practices in accordance with current regulatory requirements and industry guidance.
• Engage directly with site personnel to promote an aseptic operations culture and to provide aseptic subject matter expert knowledge.
• Provide microbiological support to the internal audit and inspection readiness programs
• Provide support for tracking and implementation of corrective and preventative actions related to microbiology and aseptic operations.
• Resolve issues, identify trends and determine system improvements.
• Must be familiar with implementation of microbiological environmental monitoring programs
• Understand interpretation of microbiological data including evaluation of trends.
• Provide microbiological evaluation of site change controls.
• Support the review and approval of microbial control related documents.
• Communicate updates, metrics and outstanding items to senior personnel as required.
• Provide assurance of consistent aseptic programs and initiatives across multiple sites.
• Mentor and develop Quality and Operations department staff.

Skills And Qualifications

• MS in Life Sciences or related field and 8+ years of relevant experience (pharma or biotech preferred). Experience should also include quality control microbiology, critical utilities and involvement with supporting regulatory inspections. Minimum of 7 years' experience working in a GMP regulated environment.
• Extensive knowledge regarding aseptic operations.
• Proven ability to formulate a compelling vision and develop a strategy with key stakeholders to achieve that vision.
• Excellent written, verbal, and interpersonal communication skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Anna Graham at (+1) 646-542-0152 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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