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Aseptic Manufacturing Supervisor
4 months ago
Salary: $100k-$125k annually
Perks: Full benefits
Schedule:
1st shift: Mon-Fri 7 AM- 4 PM
2nd shift: Mon-Fri 3 PM- 12 AM
3rd shift: Sun-Thurs 11 PM- 8 AM
Responsibilities:
- Lead a team of manufacturing technicians.
- Produce clinical and commercial material on an annual basis that meets the site's strategic objectives and is compliant with cGMPs and safety regulations.
- Performs training with staff on the floor, as needed.
- Point person on shift to assign/distribute the work and coordinate emergency situations.
- Performs training with staff on the floor, as needed.
- Maintain aseptic qualification training.
- Support and demonstrate skill set to Manufacturing Technicians I, II, and III.
- Ensure documentation (batch records and SOPs) are accurate and updated as required.
- This role is responsible for the accurate, safe, environmentally responsible, and quality-compliant operations of the manufacturing process.
- Facilitates GMP and Safety training of GMP staff, with a focus on cross-training and continuous improvement.
- Recommends equipment and supply purchases within the production areas.
- Exhibit safety leadership by example (e.g., utilize proper PPE when performing job functions)
- Responsible for shift schedule and summarizing shift progress at the end of the shift.
- Lead and mentor staff. Write performance reviews and annual goals and hold one-on-ones.
- Effectively communicate results of departmental work through team discussions and documentation
- Ensure cGMP compliance and all its related elements in documentation, reports, and records.
- Initiate non-conformances when identified and complete investigations to support on-time closure of deviation.
- Understand and review current regulations, industry guidance, and other applicable professional documentation.
- Additional duties, as assigned.
- B.S. in Engineering or Science discipline
- Minimum of 5-8 years of experience in biopharmaceutical based GMP manufacturing operations
- Must have experience in fill/finish processing
- Experience with GMP fill finish operations and sound understanding of the drug development process.
- Must have Aseptic Filling or Pharmaceutical Manufacturing experience: Background in Packaging, Pharmaceutical, Bio-Pharmaceutical, and/or Medical Devices.
- Has sound understanding and knowledge of all fill finish operations, including aseptic hand filling and automated filling of liquid vials.
- Demonstrated track record of leading or supervising hands-on cGMP manufacturing operations.
- Demonstrate skill/experience and a thorough understanding of coordinating manufacturing activities with other departments (QA, QC, MC, and other manufacturing groups) to maintain internal and project schedules.
- Must be able to comprehend and follow all applicable SOPs.
- Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
- Demonstrated knowledge of current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
- Demonstrated thorough understanding of cGMPs, industry, and regulatory standards and guidelines.
- Demonstrate experience with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
- Demonstrated ability to execute a task, unit operation, and/or document (forms and/or SOPs) with little to no assistance.
- Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
- Demonstrate the ability to work well in a cross-functional team environment.
- Must communicate fluently in English and have legible handwriting.
- Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
- Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
- Ability to lift up to 40 pounds on occasion.
- Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).
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Job Type: Permanent Post Date: 06/07/2024
If you are an associate that has already registered with Active Staffing Services, please log into your Web Portal to apply for this position. Company DescriptionActive Staffing - Electrical Division has long term Electrical opportunities available. We are a family-owned business that’s been connecting people and work for more than 70 years.Company DescriptionActive Staffing - Electrical Division has long term Electrical opportunities available. We are a family-owned business that’s been connecting people and work for more than 70 years.
