- Lead the Pen Assembly and Visual Inspection team to execute daily and weekly production schedules to meet operations objectives.
- Conduct daily shift meetings to communicate current events, issues, and solicit team feedback.
- Monitor team productivity and resolve immediate production needs to facilitate efficiency. Coordinate the teams break and lunch periods to minimize production downtime.
- Manage daily and weekly staffing requirements to account for absent personnel (PTO) to satisfy production needs. Coordinate overtime scheduling as needed.
- Monitor the inventory of department supplies. Report any quality issues and shortages to prevent production interruptions.
- Conduct training and ensure staff training is documented, current, and follows cGMP requirements.
- Review batch records, cycle reports, and other manufacturing documentation to identify and address any potential quality issues.
- Perform and/or oversee batch accountability calculations and final batch quantity confirmations.
- Provide immediate support in the identification and documentation of deviations and discrepancies.
- Support cross-departmental activities including maintenance, qualification, testing, and investigational activities.
- Assist in the development and update of manufacturing procedures and training materials.
- Perform other duties as assigned by manufacturing management.
- Assist R&D and MSAT on new product introduction and tech transfer activities to meet commercial demand.
- Initiate and complete manufacturing investigations including root cause analysis and product impact assessment.
- Assist in the revision, and management of manufacturing documents such as Batch Records and SOPs.
- Associate degree with 8+ years demonstrated ability in a cGMP production environment.
- High School degree with 10 years of experience of cGMP production experience may be considered.
- Experience in a sterile fill finish facility.
- 2+ years of supervisory experience.
- Strong writing and documentation skills.
- Ability to perform mathematical calculations that include exponents, scientific notation, orders of operation, algebra, and unit conversion.
- Proficiency in Microsoft Office applications.
- Experience with Pen Assemble and/or Visual Inspection strongly preferred.
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Supervisor, Manufacturing - Petersburg, United States - Civica
4 days ago
Description
Essential Duties and Responsibilities
:Basic Qualifications and Capabilities:
Preferred Qualifications:
Position ID: 518
Shift: 7:00 am 3:30 pm. Monday through Friday.
