Aseptic Pharma Production Lead

Exela Pharma Sciences LLC; North Carolina; Sur place; USD 65 000 - 90 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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

Connaissances

aseptic practices

cleanroom behavior

accountability

garb compliance

analytical skills

communication skills

time management

problem solving

attention to detail

organization

interpersonal skills

computer skills

Formation

Associates degree (highly preferred)

3+ years cGMP manufacturing experience

Description du poste

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