IT Quality Assurance Director jobs in Nassau, NY

We are currently looking to fill an Associate Director QA Microbiology position. This position focuses on supporting the improvement of practices and procedures that ensure the efficiency of the Contamination and Microbial control programs. Also assess, justify and support the implementation of new technologies to help support product safety. In addition, this position will support the goal of zero regulatory observations by partnering with the GMP Compliance & Inspections team with inspection preparations and regulatory inspections.

In this role, a typical day might include the following:

• Improving upon and maintaining the general facility bioburden program and remediation efforts

• Leading investigations pertaining to microbial contamination to assure effective root-cause analysis, corrective action plans determination and remediation plans

• Maintaining industry standards with respect to microbial control and mitigation – incorporate any new industry standards/use of new monitoring equipment

• Providing input on technology transfer plans related to microbiological method transfers (method validation)

• Developing and providing input on the development and modification of microbial action limits

• Reviewing and providing input on microbiology SOPs, microbiology assay validation and related documentation

• Reviewing and providing input on environmental monitoring SOPs and validation

• Reviewing and providing strategic support to understanding and managing bioburden trend levels

• Assessing the efficiency of sanitization agents

This role may be for you if you:

• Have knowledge and experience in qualifying clean rooms, clean utilities and manufacturing processes

• Have experience in quality control microbiology, quality assurance and regulatory inspections for Biological pharmaceuticals

• Excel in a quality driven organization

To be considered for this role you must hold a Master’s or Bachelor’s degree in a microbiology, medical technology, biology or related field and a minimum of 10 years experience in the pharmaceutical or biotechnology industry.

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