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Organization Overview:

The QA Sterility Assurance associate is a member of the Quality Assurance team and teaches, mentors, and guides on sterility assurance related matters in partnership with Sterility Assurance Subject Matter Experts and Management. Acting as a subject matter expert for sterility assurance and microbiology, this individual operates cross-functionally and in partnership with Technical Services/Manufacturing Sciences Sterility Assurance Team (TS/MS SAT) to improve the site Sterility Assurance related processes and programs (aseptic training / qualification, APS program, EM program, etc.). This individual is responsible for writing, reviewing and / or approving strategy documents, standards and procedures related to Sterility Assurance Programs, ensuring they are aligned with all appropriate quality standards and current regulatory and industry expectations. This individual will participate in regulatory inspections and collaborate in site inspection readiness program and assist in investigations related to sterility assurance matters.

Responsibilities:

• Maintain a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.

• Teach, mentor, and guide site quality personnel on sterility assurance related matters in partnership with Sterility Assurance Subject Matter Experts and Management. Share findings, lessons learned, etc., related to Sterility Assurance matters and topics, with the QA organization to ensure continuous professional development of the organization.

• Lead the quality oversight program for aseptic operations, including developing training material for aseptic observation and teaching and mentoring QA floor support and Sr. QA floor specialists in aseptic processing quality and compliance attributes.

• Partner with TS/MS Sterility Assurance and the Learning & Development Organization to design, develop and implement the overall site training & qualification program related to aseptic operations.

• Support knowledge development for the Quality organization related to sterility assurance expertise

• Participate in site inspection readiness by preparing SMEs on Sterility Assurance topics and participate in regulatory and internal audits including response to observations/recommendations.

• Write, review and/or approve documents related to sterility assurance and microbiological related topics, ensuring they are aligned with regulatory expectations, internal standards and industry practices. May serve as Quality Approver for SAT documents requiring equivalent level (i.e., R4-R6 for M2, R7 for M3).

• Assist with troubleshooting and investigations related to significant sterility assurance and / or microbiological matters.

• Escalate sterility assurance quality concerns, inspection risks or strategic misalignment issues to site Quality Leader and the Site Lead Team.

• Establish a strong communication and cross-functional team to work with the plants and TS/MS Sterility Assurance for microbiological and Sterility Assurance related topics. Provide inputs to the continuous improvement efforts.

• Participate in the Site Quality Lead Team (SQLT) and other cross functional governance bodies, as applicable.

• Network and benchmark with other sites to identify best practices and optimize site processes related to Sterility Assurance. Participate in global and network harmonization groups and projects.

• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group

Basic Requirements:

• 7+ years directly supporting aseptic manufacturing, sterility assurance, environmental monitoring or equivalent roles

• Bachelor degree in biological science (microbiology/applied microbiology preferred)

Additional Skills/Preferences:

• Previous experience in creation or management of Contamination Control Strategies

• Previous facility or area start up experience

• Previous equipment qualification and process validation experience

• Previous experience with highly automated parenteral manufacturing processes including isolators, automated inspection, etc.

• Previous experience with Manufacturing Execution Systems and electronic batch release

• CQM, CQE, or CQA certification from the American Society for Quality (ASQ)

• Previous experience with Trackwise, Veeva, MODA

• Previous experience leading or working effectively with a cross functional group

• Strong knowledge of Quality Management Systems and applicable regulatory requirements

• Technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the industry (e.g. filling technology, Annex 1 interpretation)

• Previous regulatory inspection readiness and inspection execution experience

• Excellent interpersonal, written and oral communication skills

• Strong technical aptitude and ability to train and mentor others

Additional Information:

• Ability to work 8-hour days – Monday through Friday

• Ability to work overtime as required to support 24/7 operation

• Ability to travel up to 10% to Indianapolis, IN for meetings and coordination with global organizations.

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