Sterility Assurance Lead Position Overview
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We are seeking an experienced Sterility Assurance Lead to join our quality organization. In this role, you will be responsible for ensuring the site's sterility program is effectively implemented and maintained.
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The ideal candidate will have a strong background in microbiology or a related field, with experience working in aseptic sterile fill finish manufacturing environments. You will work closely with operations and quality teams to develop and implement contamination control strategies, training programs, and monitoring protocols.
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Key Responsibilities:
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* Develop and maintain the site's contamination control strategy.
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* Work with operations to develop training programs for aseptic processing.
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* Provide training on aseptic behaviors and principles to site staff.
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* Establish and maintain clean utilities and environmental monitoring programs in conjunction with the QC Micro Lab.
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* Collaborate with operations to establish gowning and cleaning/sanitization programs.
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* Monitor and review microbiological data to detect trends.
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* Liaise with global S&T to ensure best practices are in place for sterility assurance.
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* Provide technical guidance on contamination-related non-conformances or events.
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Requirements:
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* A Third level qualification to degree level in a relevant technical discipline (science/engineering) (Microbiology Qualification desirable)
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* Minimum 4 years' experience in the pharmaceutical industry or biopharma industry in Quality/Operations role
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* Experience in an aseptic sterile fill finish manufacturing environment
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* Proven ability to work cross-functionally
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Benefits:
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This is a challenging and rewarding role that offers opportunities for career development and growth. We offer a competitive salary and benefits package as well as a collaborative and dynamic work environment.
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What You Will Be Doing:
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In this role, you will be responsible for leading aseptic processing training and execution. You will also act as the site SME on compliance and provide guidance on same.
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Expected to influence operations area owners to ensure that quality issues are identified and appropriate corrective actions are implemented to maintain compliance.
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This position requires a high degree of professionalism, excellent communication skills, and the ability to work effectively in a team environment. If you have a strong background in microbiology or a related field and are looking for a new challenge, we encourage you to apply for this exciting opportunity.
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