Group Lead, Finishing

Position Summary:

A Group Lead, Finishing is responsible for coordinating daily finishing activities and completing associated documentation in support of inspecting, packaging and/or labeling pharmaceutical products in compliance with all safety policies, cGMPs, and SOPs. The Group Lead, Finishing will rely on experience and judgment to plan and accomplish goals. In addition, Group Leads perform various roles as directed by the department supervisor such as: organize hourly employees in the performance of their duties, drive employee and equipment productivity to achieve optimum results, and coordinate labor needs in support of achieving production schedule attainment. This position supports the ongoing development, manufacture, and distribution of pharmaceutical products in compliance with local procedures, corporate policies, and the regulatory requirements of the U.S. Food and Drug Administration.  

Job Responsibilities: 

• Comply with garbing and behavior requirements that align to established cGMP practices for pharmaceutical finishing activities
• Follow/enforce Standard Operating Procedures (SOPs), batch records, current Good Manufacturing Practices (cGMP), including Data Integrity and Good Documentation Practices (GDocP)
• Oversee/execute the set-up, operations, troubleshooting/resolution of equipment 
• Complete line clearance/changeover activities for finishing production
• Prevent product/label mix-ups
• Guide the finishing team to perform responsibilities associated with inspection, packaging, labeling, packing, palletizing, cleaning, reconciliation, traceability, training, and/or accurate and timely completion of finishing batch records and paperwork
• Ensure self and finishing team members are trained and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety, environmental and company policies
• Perform other duties as assigned

Required Skills:

• Must display sound judgment, ability to see guidance, and follow directions
• Strong analytical, listening, verbal communication, achieve accuracy without being rushed, efficient time-management, problem-solving, attention to detail, prioritization, organization, interpersonal, and conflict management skills
• Good hygiene
• Basic math skills (addition, subtraction, division)

• Physically able to lift 30 lbs, able to stand for extended periods of time 

• Documented vision of 20/20 (corrective lenses permitted) as demonstrated by a current eye exam for inspection activities

Education and Experience Requirements: 

High School Diploma or equivalent required; Associate degree preferred