Role Summary
Supervise packaging department activities and personnel while ensuring full compliance with cGMP, SOPs, EHS, DEA, Union Shop Floor Requirements, Company Policies, and applicable regulatory requirements.
Responsibilities
- Supervise the filling and packaging of solid dose products.
- Direct, coordinate, and support Union employees in the Packaging Department.
- Ensure all departmental activities are performed in accordance with cGMP requirements.
- Write, revise, and update SOPs pertaining to packaging operations and review updates with employees.
- Train packaging personnel on revised procedures, new equipment, and new applications.
- Maintain a strong focus on quality, safety, and efficiency, continuously evaluating work practices for improvement opportunities.
- Supervise and support the Printed Materials area, including bottle labels and outserts.
- Perform Packaging Batch Record Reviews and process work orders in the ERP system.
- Initiate and support Change Control requests related to Master Packaging Records (MPRs) and SOP updates.
- Support Master Packaging Record review activities for accuracy and compliance.
- Ensure security, accountability, and proper inventory control for materials and finished goods.
- Recommend process improvements to increase departmental efficiency.
- Ensure adherence to packaging standards and administer disciplinary action when required.
- Work within the approved annual operational budget.
- Conduct thorough investigations of packaging deficiencies and document findings appropriately.
- Collaborate with cross functional departments to support production requirements.
- Ensure OSHA standards are maintained by promoting and enforcing a clean and safe work environment.
- Identify and prevent health and safety issues (dress code, hygiene, equipment condition, etc.); report and document accidents/incidents per proper procedures.
- Provide input and maintain accuracy within the Inventory Control (ERP) system.
- Perform other duties as assigned by the Manager/Director.
- Build accountability on the shop floor by following Union work rules and issuing disciplinary actions when appropriate.
- Maintain the Employee Time Card System, including work hours, vacation, leave of absence, and overtime control.
- Identify and implement production process improvements to enhance quality, reduce cost, and improve safety.
- Must be able to read, write, speak, and comprehend English.
- Actively participate in OPEX and Lean Manufacturing initiatives.
- Routinely inspect packaging lines, equipment washrooms, clean equipment storage areas, and material staging areas to ensure compliance.
Qualifications
- High School diploma required; BS/BA in a science or related field preferred.
- 2–5 years of supervisory experience within a pharmaceutical manufacturing or packaging environment.
- Solid dose packaging experience is highly preferred.
- Knowledge of Solid Oral Dose packaging equipment and familiarity with various packaging machinery (tablet/capsule fillers, cappers, labelers, etc.).
- Ability to understand and operate vision inspection systems (e.g., Optel) and support setup and troubleshooting.
- Strong working knowledge of pharmaceutical cGMP requirements.
- Demonstrated ability to adapt to change, support multiple shifts when necessary, and manage shifting priorities.
- Proven ability to follow production schedules, meet deadlines, and learn new systems and operational processes.
- Excellent verbal and written communication skills, with effective interpersonal abilities.
- Self-motivated, team-oriented, and capable of working independently.
- Proficiency with Microsoft Office (Word, Excel), TrackWise, Document Control Systems, and ERP systems.
- Physical ability to lift up to 25 lbs., and walk, stand, or sit as needed.