Production Supervisor in Schenectady, NY

3rd shift Sunday – Thursday 11pm -7am (plus prep to start and close shift)

3 months (covering LOA)

Job Description:

Responsible for the daily supervision of operating personnel in the production of clinical or commercial products. Works in concert with other supervisors. Responsible for the accurate and timely completion of producation related cGMP documentation. Facilitates the transfer, planning, implementation, and maintenance of manufacturing processes and procedures. Ensures the efective use of material, equipment, and personnel in producing quality products.

• Develops weekly goals and schedules and set priorities for staff. Reviews weekly production schedule and priorities to determine unit assignments and critical actions.
• Reviews all materials and batch records required to support shift and any off shift needs for the day.
• Provides on the floor training to support formalized technical and GMP training.
•  Check that operator training files match and support the processes they are required to carry out.
• Monitors operator training files and work with compliance specialist to keep files up to date.
• Works with QA and Subject Matter Expert (Tech Ops or Process Sciences) to resolve exceptions. Reviews new Batch records and SOPs.
• Works with technology transfer team to incorporate new processes in the plant. Works interdepartmentally to see that work orders, dispensing, preventative maintenance, QC, and documentation issues are resolved and enhances communications at all levels.
• Ensures that direct materials budgets and overtime budgets are met.
• Provides supervision primarily to skilled nonexempt and junior level exempt employees. Acts as advisor to unit or sub-unit, becomes actively involved as required. Acts as mentor for less senior personnel. Evaluates staff performance.
• Ensures compliance with all applicable local, state, and federal regulatory requirements which include but are not limited to: OSHA Process Safety Management (PSM) standard (29 CFR 1910.119) and EPA & Risk Management Planning (RMP) rule (40 CFR 68), Mechanical Integrity programs, PCI, DOT, EPA etc.
• Creates a safety culture by setting direction to reduce or eliminate operations-related injuries or accidents, damage/loss of product or equipment, and unnecessary costs by ensuring that all equipment and facilities are maintained consistent with the safety, security, hygiene and standards set by Client.

Are you open to look at candidates willing to relocate? No

Years of experience/education and/or certifications required:

 Requires a Bachelor’s degree or equivalent; Eight plus years’ experience in all aspects of manufacturing/production processes

What are the top 3-5 skills requirements should this person have?

• Computer proficiency and scheduling experience required; good writing skills.
• Working knowledge of safety, quality systems, and cGMPs is required
• Familiarity with industrial automation (e.g., distributed control and PLC-based systems
• Familiarity with equipment and facilities validation

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?

• OEE experience – Operational Equipment Efficiency
• Infor experience – scheduling program

What type of environment is this person working in?

• Packaging/production – clean room (fully gowned – steel toe required)

Work Schedule (Define days,# of hours)/ Is Overtime offered or required?

• 3rd shift Sunday – Thursday 11pm -7am (plus prep to start and close shift)
• OT Mandatory – weekends rotate

Does this position offer the ability to work ly on a regular basis or is it an on-site role? If  opportunity exists, what are the options (i.e. 1 day , 4 days on-site)?

• Onsite required

Is the worker onshore or offshore? (If offshore confirm with manager that the worker will align to a USD Cost Center for invoicing purposes.) If no, escalate to Operations Manager

• Onshore

Will there be Domestic and/or International Travel?

• If yes, list proposed countries and % of time travelling:

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