Sterile Packaging Lead – 2nd Shift

INCOG BioPharma Services; Fishers (IN); Vor Ort; USD 65.000 - 90.000; Vollzeit

Zusammenfassung

INCOG BioPharma Services is seeking a Packaging Lead to oversee sterile product packaging operations in our Fishers, Indiana facility. The role involves monitoring packaging processes, reviewing batch records, and driving team activities to meet production standards while ensuring quality and minimizing downtime.

The SME will ensure CGMP compliance, collaborate with internal teams and clients, and train new staff.

Qualifikationen

• High School diploma required, minimum 1 year of GMP pharmaceutical experience in drug product inspection and/or packaging.
• Awareness of regulatory requirements and guidelines applicable to CGMPs for pharmaceutical packaging and sterile products.

Aufgaben

• Assist Packaging Supervision, supporting a team of 6 to 10 associates daily, to package syringes, vials and device assemblies.
• Follow production and manufacturing procedures.
• Perform in-process checks to identify packaging defects and machinery issues.
• Escalate packaging issues to Supervision as required.
• Perform reconciliation of finished packaged product and defects.
• Provide input for process and document improvements.
• Operate equipment in compliance with SOPs.
• Assure compliance with cGMP requirements.
• Perform label and packaging activities for finished product.
• Complete and review associated production records, logbooks and forms.
• Assist other manufacturing functions as required.
• Train new employees to perform packaging activities.
• Collaborate and communicate with cross functional teams.
• Work flexible hours to ensure production facility coverage.

Ausbildung

High School diploma

Jobbeschreibung

INCOG BioPharma Services is seeking a Packaging Lead to oversee sterile product packaging operations in our Fishers, Indiana facility. The role involves monitoring packaging processes, reviewing batch records, and driving team activities to meet production standards while ensuring quality and minimizing downtime.

The SME will ensure CGMP compliance, collaborate with internal teams and clients, and train new staff.