The Aseptic Compliance Manager is a key member of the Quality Assurance Team, responsible for designing, implementing, and continuously improving the Aseptic Observer Program. This program ensures quality oversight of sterile injectable filling operations, supporting compliance with regulatory requirements and maintaining the highest standards of safety, identity, strength, purity, and quality (SISPQ).

ROLE SUMMARY

The Aseptic Compliance Manager is a key member of the Quality Assurance Team, responsible for designing, implementing, and continuously improving the Aseptic Observer Program. This program ensures quality oversight of sterile injectable filling operations, supporting compliance with regulatory requirements and maintaining the highest standards of safety, identity, strength, purity, and quality (SISPQ).

ROLE RESPONSIBILITIES

• Program Design & Oversight: Develop and maintain the Aseptic Observer Program, including audit protocols, checklists, and documentation requirements
• Quality Systems: Implement and enhance quality systems to support aseptic filling operations, ensuring alignment with cGMP and regulatory standards
• Training & Development: Lead and improve the aseptic behavior training program, incorporating industry best practices and contamination control strategies.
• Cross-Functional Collaboration: Partner with Manufacturing leadership, training leadership, and the Contamination Control Strategy owners to address quality risks and process improvements.
• Compliance & Audits: Conduct and review aseptic filling audits, root cause analyses, and corrective/preventive actions (CAPA)
• Process Improvement: Drive continuous improvement initiatives to enhance efficiency, reduce contamination risk, and ensure product integrity
• Culture & Standards: Foster a culture of teamwork, productivity, and quality excellence, ensuring SISPQ is embedded in daily operations.
• Metrics & Reporting: Prepare and present aseptic behavior metrics to leadership.

BASIC QUALIFICATIONS

EDUCATION:

Bachelor's degree in science preferred (Microbiology, Biology, Biochemistry, Chemistry, Engineering, Pharmacy, or related science)

EXPERIENCE:

Minimum of 10 years previous experience in sterile manufacturing, aseptic processing and quality assurance in a pharmaceutical/biotech environment.

TECHNICAL SKILLS:

• Strong knowledge of cGMP, FDA/EMA regulations, and contamination control strategies.
• Proficiency in audit methodologies, root cause analysis, and CAPA systems.
• Proficiency in metrics design and presentation.
• The capability to aseptically gown and maintain various levels of certification to enter and support the manufacturing areas.
• The capability to focus attention on colleagues' behaviors that in turn leads to higher-than-normal performance.
• Ability to hold self and others accountable and to encourage colleagues to take personal responsibility for their performance / actions.
• Ability to coach by providing constructive feedback combined with a willingness to develop and listen to colleague ideas.
  Demonstrated aptitude to execute aseptic techniques to a high degree of proficiency.
• Must be able to communicate, present, and work well with all facility departments.
• Promote a positive team environment while performing all tasks in a safe manner.
  Excellent communication, leadership, and problem-solving skills.
• Job duties involve occasional lifting (less than 35 lbs.), reaching, and sitting while working at computer terminal.

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