Responsible for supervising and monitoring the daily activities of the cleaning, compounding and/or packaging area, completing and auditing of all processing documentation, ensuring that the area runs smoothly and efficiently and for assuring that all procedures, policies, and standards are maintained.
- Supervises, schedules and assigns the daily activities in the cleaning, compounding and/or packaging areas.
- Supervises Manufacturing Set-up Technicians and Label Room Operator as needed.
- Ensures all current Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs) and policies are followed.
- Reviews cleaning, compounding and/or packaging area documentation for accuracy and completeness.
- Authors and/or assists in investigations/reports.
- Operates compounding and/or packaging area equipment.
- Conducts training of cleaning, compounding and/or packaging personnel on all SOPs, batch records, documentation and policies.
- Assists department management when needed to ensure maximum efficiency, quality, safety and productivity.
- Assists with writing, reviewing and revising cleaning/compounding/packaging area documentation including SOPs, batch records, forms and schedules.
- Maintains job results through coaching, counseling and disciplining of employees.
- Maintains proper staffing by closely monitoring personnel requirements.
- Executes and/or assists with scheduling the manufacturing and packaging of products on the applicable equipment.
- Writes and/or conducts employee performance reviews.
- Assures manufacturing personnel are trained on essential job functions and safety procedures.
- Works with other departments to schedule activities (i.e., process validation, calibration, cleaning checks, cleaning validation, PQ's etc.) in manufacturing.
- Assists with the recommendation of new compounding and packaging equipment.
- All other duties as assigned.
Knowledge, Skills & Abilities
Minimum 1 year prior supervisory experience preferably in an FDA-regulated facility. Requires good verbal and written communication skills and the ability to interact effectively with subordinates, peers and management. Proven organizational and time management skills. Basic computer skills including knowledge of Microsoft Windows, Word and Excel. Basic math skills and knowledge of HMI’s (Human machine interface) for operation of automatic/semi-automatic compounding or packaging equipment. Strong knowledge of packaging equipment or methods of compounding semi-solid liquid pharmaceutical products. Knowledge of MFG/PRO inventory control system.
Requires an Associate Degree or High School Diploma or equivalent with Manufacturing supervision experience in pharmaceutical or similar industry.
EO Employer M/F/Vets/Disabled