Location: Buena, NJ
The Aseptic Process Supervisor will be responsible for required functions to support all Aseptic Manufacturing Operations to ensure the sterility of Teligent’s products. This person will ensure that all activities in the Aseptic area are performed following FDA regulations, in compliance with all cGMP’s, SOP’s, Company Policy, and batch record procedures.
Reporting Relationships: Individual contributor
- Ensure the quality of all Sterile product.
- Maintain cGMP’s throughout aseptic production, inspection, and secondary packaging areas.
- Support the Microbiology department to address environmental concerns and proactively prevent reoccurrences by scheduling routine aseptic areas cleaning and disinfection.
- Responsible for Aseptic techniques and development of all Sterile employees.
- Ensure Sterile employees are trained and qualified for the functions they perform.
- Review, edit, and generate SOP’s as required.
- Assist with the editing and improvement of batch records.
- Report and investigate departmental non-conformities.
- Follow aseptic processing and/or sterilization process for products, and the sites for execution.
- Stay current on new regulatory expectations for aseptic and TS manufacturing and ensure site compliance.
- Monitor all production areas through routine inspections and correct any less than acceptable issues.
- Maintain a clean and safe work environment through routine inspections and correct any less than acceptable issues.
- Support the Product Development department to develop technical competencies for future products.
- Work directly with Quality Control (Microbiology and Chemistry), Quality Assurance and Supply Chain for receiving, testing and release of raw materials, components and other materials to be used for the manufacturing of Sterile products.
- Monitor equipment for necessary maintenance, improvements, or upgrades.
- Provide support to inspections and audits by internal and external agencies.
- Implement and maintain Lean initiatives to maximize safe and efficient working conditions.
- Assume other activities and responsibilities as directed.
- Minimum Bachelor’s degree in a science or technical degree.
- 3-5 years supervisory experience in a cGMP batch manufacturing environment preferred.
- Minimum 3 years’ experience in aseptic production and media fill programs is required.
- Must pass Teligent vision screening exam for close-up and color acuity performed by an approved eye care professional.
- Experience with manual inspection, sterile isolator technology, automated washers, and autoclaves preferred.
- Self-starter with strong analytical and reasoning abilities.
- Participative management type – advocates team concept.
- Well-developed interpersonal skills. Ability to get along with diverse personalities.
- Ability to establish credibility and be decisive, but able to recognize and support the organization’s preferences and priorities.
- Excellent computer and math skills.
- Good communication skills, written and verbal.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- While performing the duties of this job, the employee is regularly required to talk or hear.
- The employee frequently is required to stand; walk; use hands to handle or feel; and reach with hands and arms.
- The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
- Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- The employee must be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.