Supervisor, Formulation and Fill - 2nd shift

SUN PHARMA; Billerica (MA); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

SUN PHARMA in Massachusetts is seeking a 2nd shift supervisor (1:30PM - 10:00PM) to lead technicians in the preparation, formulation and dispensing of pharmaceutical products under cGMP and SOPs in a clean room. The role emphasizes investigations, CAPAs, deviations and change controls using root cause analysis and reporting software.

Responsibilities include scheduling, inventory oversight, equipment troubleshooting and ensuring batch records meet specifications.

Qualifikationen

• Bachelor's degree in related field or equivalent experience.
• 6 to 8 years of experience in pharmaceutical manufacturing.
• Experience with supervisory roles and team management.
• Strong communication and documentation skills.
• Knowledge of SAP, GMP, GDP, FDA, and OSHA regulations.
• Experience with aseptic processing.

Aufgaben

• Supervise second shift technicians in API/excipients preparation and parenteral products.
• Schedule weekly floor activities for second shift.
• Author and track investigations, CAPAs, deviations and change controls.
• Troubleshoot and solve equipment/process problems.
• Oversee inventory control and order supplies to avoid delays.
• Use SAP, TrackWise, EDMS systems.
• Evaluate team performance with midyear/yearly reviews.
• Review batch records for specification compliance.
• Review SOPs and Batch Records with DCR updates.
• Work under limited supervision and follow procedures.

Kenntnisse

Team leadership

Verbal communication

Written communication

Interpersonal skills

Ausbildung

Bachelor's degree in related field

Tools

SAP

TrackWise

EDMS

Jobbeschreibung

Job Summary

This position is a 2nd shift role, 1:30PM - 10:00PM. Supervise and perform regularly the preparation, formulation and dispensing of pharmaceutical products according to our current Good Manufacturing (cGMPs) and utilize Standard Operating Procedures (SOPs) in a clean room environment. Write and complete investigations, CAPAs, deviations and change controls utilizing root cause analysis tools and reporting software.

Area Of Responsibility

• Supervise and perform the activities of technicians on the second shift in equipment and component preparation operations; dispensing API and excipients; formulation and filling and capping of parenteral drug products. Also responsible for overseeing the formulation and filling of dermatological drug products.
• Schedule weekly plan of floor activities for technicians on second shift
• Author and track to close investigations, CAPAS, deviations and change controls as required
• Troubleshoot and solve moderate to complex problems related to the equipment, processes; existing or new products
• Oversee inventory control in the production area and order supplies as needed for production to assure no delay in the manufacturing plan
• Use systems like SAP, Track Wise, EDMS etc.
• Evaluate team performance by conducting midyear and yearly reviews
• Review completed batch records to ensure product is made in accordance with specifications
• Review SOPs and Batch Records, and update through DCRs as needed
• Work under limited supervision and follows clearly described procedures
• Other duties as assigned
• Education in Life sciences or technical discipline

Work Conditions

• Lab
• Clean room/controlled classified areas
• Manufacturing/production areas
• Office
• Exposure to noise
• Exposure to Chemical/Biological hazards
• Exposure to non-hazardous chemicals
• Exposure to radiation within NRC limits
• Exposure to/use of syringes and needles
• Must wear scrubs/coveralls, safety glasses, safety shoes, gloves as required

Physical Requirements

• Stand, walk, sit, use hands and fingers to handle or feel, reach or push with hands and arms, stoop, kneel, crouch or crawl, climb, talk and hear
• Able to operate lab equipment, production equipment and computer/office machines
• Ability to wear Personal Protection Equipment
• Lift up to 50 lbs.

Travel Estimate

Up to 0%

Education and Job Qualification

• Bachelor's degree in related field or equivalent experience
• 6 to 8 years of experience in pharmaceutical manufacturing
• Excellent verbal, written and interpersonal communication skills
• High level of initiative and self-motivation
• Strong computer skills
• Attention to detail
• Ability to plan, prioritize and organize diversified workload
• Team management skills
• Record keeping skills
• Safe chemical handling techniques
• Knowledge of SAP, GMP, GDP, FDA, and OSHA regulations and standards

Experience

• Minimum 2 - 5 years of supervisory or team lead experience
• 5 to 7 years of aseptic processing and aseptic area techniques experience
• Experience with technical writing, root cause analysis and completing investigations, CAPAs, deviations and change controls