Production Supervisor (Nights/Weekends)

Exela Pharma Sciences LLC; North Carolina; On-site; USD 65,000 - 90,000; Full time

Job summary

Exela Pharma Sciences LLC is seeking a Supervisor, Production to lead daily production personnel, ensure cGMP compliance, and manage documentation in a cleanroom environment. The role emphasizes coaching, safety, and adherence to SOPs to support ongoing development, manufacture, and distribution of pharmaceutical products.

The position requires experience in a cGMP manufacturing setting, familiarity with aseptic processes, and strong leadership to optimize productivity and quality while

Qualifications

• Associates degree (highly preferred) and 3 years of experience in a cGMP manufacturing environment.
• Equivalent combination of education and experience may be considered in lieu of a formal degree.
• 1 year or more of experience in a supervisory role in industrial setting preferred.

Responsibilities

• Enforce/Maintain clean room protocols by complying with garbing and behavior requirements that align to established cGMP practices and techniques
• Enforce/follow Standard Operating Procedures (SOPs), batch records, current Good Manufacturing Practices (cGMP), including Data Integrity and Good Documentation Practices (GDocP)
• Oversee the set-up, operations, troubleshooting/resolution of equipment
• Ensure line clearance/changeovers are completed accurately and efficiently
• Supervise direct reports to accurately and efficiently perform responsibilities associated with aseptic or terminally sterilized product preparation, compounding, filling, palletizing, and/or accurate as well as timely completion of batch records and production paperwork
• Oversee routine aseptic interventions and cleaning activities
• Conduct employee reviews and provide coaching as appropriate; maintain performance and attendance records
• Conduct shift hand-off meetings, to ensure support/continuity of production plan
• Ensure self and direct reports are trained and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety, environmental and company policies
• Perform other duties as assigned

Skills

aseptic practices

cleanroom behavior

accountability

garb compliance

analytical skills

communication skills

time management

problem solving

attention to detail

organization

interpersonal skills

computer skills

Education

Associates degree (highly preferred)

3+ years cGMP manufacturing experience

Job description

Position Summary:

The Supervisor, Production is responsible for leading daily production personnel activities and completing associated documentation in support of producing pharmaceutical products in compliance with all safety policies, cGMPs, and SOPs. The Supervisor, Production will rely on experience and judgment to plan and accomplish goals. In addition, Supervisors will 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:

• Enforce/Maintain clean room protocols by complying with garbing and behavior requirements that align to established cGMP practices and techniques


• Enforce/follow Standard Operating Procedures (SOPs), batch records, current Good Manufacturing Practices (cGMP), including Data Integrity and Good Documentation Practices (GDocP)


• Oversee the set-up, operations, troubleshooting/resolution of equipment


• Ensure line clearance/changeovers are completed accurately and efficiently


• Supervise direct reports to accurately and efficiently perform responsibilities associated with aseptic or terminally sterilized product preparation, compounding, filling, palletizing, and/or accurate as well as timely completion of batch records and production paperwork


• Oversee routine aseptic interventions and cleaning activities


• Conduct employee reviews and provide coaching as appropriate; maintain performance and attendance records

• Conduct shift hand-off meetings, to ensure support/continuity of production plan

• Ensure self and direct reports are trained and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety, environmental and company policies


• Perform other duties as assigned

Required Skills:

• Ability to comply with and enforce aseptic practices and cleanroom behavior


• Ability to hold employees accountable for accurate, complete and timely task execution


• Ability to wear full cleanroom garb for up to 5 hours at a time


• Ability to manufacture product in a compliant manner employing accuracy and efficiency


• Must display sound judgment, ability to seek guidance, and provide clear directions


• Strong analytical, listening, verbal/written communication, achieve accuracy without being rushed, efficient time-management, problem-solving, attention to detail, prioritization, organization, interpersonal, computer and conflict management skills


• Basic math skills (addition, subtraction, division)


• Must be mechanically inclined and physically able to lift up to 20 pounds continuously


• Able to stand for extended periods of time and work in confined spaces

Experience and Education Requirements:

• Associates degree (highly preferred) and 3 years of experience in a cGMP manufacturing environment. Equivalent combination of education and experience may be considered in lieu of a formal degree.


• 1 year or more of experience in a supervisory role in industrial setting preferred.