What are the responsibilities and job description for the Shift Manager - Aseptic Operations position at PeopleSuite Talent Solutions?
Job Description
Job Description
Scope of Position
We are seeking an experienced and motivated Shift Manager for Aseptic Operations to provide leadership and direction in overseeing Aseptic Manufacturing processes, including formulation and filling activities. This role will collaborate closely with teams across Operations, Quality Assurance, Technical Services, Validation, Quality Control (Microbiology and Analytical Chemistry), Business, and Finance to ensure seamless and compliant production.
Responsibilities
- Provide strong leadership to Aseptic Manufacturing Associates, including hiring, training, coaching, and performance management.
- Oversee Aseptic Manufacturing operations across all shifts, with flexibility for weekend support as needed.
- Manage day-to-day manufacturing activities, including scheduling, raw material / consumable management, and resource allocation.
- Ensure accurate documentation and completion of internal batch record reviews.
- Assist in authoring, reviewing, and implementing manufacturing procedures and master batch records.
- Lead component preparation, bulk drug formulation, aseptic filling, and equipment operation activities.
- Maintain cGMP compliance through routine quality assurance checks and staff training.
- Perform and train staff in sterile manufacturing tasks, including gowning, media fill qualification, lyophilization, and sterile filling.
- Participate in client communications, audits, and regulatory inspections, providing necessary documentation and support.
- Review and approve cGMP documentation, including SOPs, batch records, risk assessments, and training curricula.
- Identify continuous improvement opportunities to enhance efficiency and compliance.
Qualifications
