Post Production Operator

Summary

To provide a cGMP compliant manufacturing process and continuously improve the pharmaceutical manufacturing environment. Create a workplace that is safe, clean, environmentally friendly, employee friendly, highly productive, efficient and of sufficient capacity to support the forecasted demand as predicted. Finishing Operator performs quality inspections to identify and remove sub-standard quality soft gels and foreign materials from product lots according to Standard Operating Procedures and applying current Good Manufacturing Practices (cGMP).

Key Responsibilities

• Follows all Standard Operation Procedures (S.O.P.’s) relating to processes.
• Immediately brings any discrepancies to the attention of a supervisor before continuing in processes.
• Performs hardness testing of capsules following batch records.
• Helps in spreading soft gels on trays.
• Dumps capsules once testing and drying is complete.
• Weighs capsules in bulk for storage until next process begins according to batch records.
• Performs inspection of soft gels when necessary.
• Performs room cleanings of major and minor change overs.
• Gets clearance from QA on appropriate equipment and GMP rooms for processing.
• Fills out appropriate batch paperwork and maintains good documentation practices.
• Perform inspection of all components and change parts for equipment to ensure best practices are being met.
• Cross training in performing tasks, operating equipment and maintaining the necessary documentation in other production departments may be required.
• Depending on shift staffing level and /or the workload, an operator could be assigned to perform tasks in area, different than her/his primary positions/business unit.
• Responsible for following current Good Manufacturing Practices (cGMP’s), 21 CFR Part 111 & 117.
• Other duties which may be assigned from time to time by management of the company.

Education and Experience

• High school diploma or GED (General Educations Diploma).
• 2+ years of experience; or equivalent combination of education and experience.
• Able to read and follow SOPs.
• Able to work in compliance with current GMPs.
• Able to perform basic math calculations (add, subtract, multiply, divide).
• Able to perform weighing.
• Able to follow written and verbal instructions.

Knowledge, Skills and Abilities

• Understanding of SOPs.
• Will be required to follow gowning requirements and wear Personal Protective Equipment (PPE) over head, face, hands, and arms.
• Train in dumping and inspection processes.
• Perform inspections.
• Cleans process equipment.
• Inspects all equipment and component parts for wear and tear.
• Performs major and minor clearances.
• Maintains neat and clean work areas.
• Works efficiently.
• Maintains a safe work environment.
• Understands weighing.
• In-process testing/sampling.
• Attention to detail.
• Cross training with other departments and tasks.
• Must execute good documentation practices.
• Executes good trouble shooting skills.

Physical/ Work Environment/ Expectations

• This position works within a GMP Manufacturing Environment, office environment, and inside the plant
• Must be able to work in controlled environments requiring special gowning
• Will be required to follow gowning requirements and wear Personal Protective Equipment (PPE) over the head, face, hands, and arms
• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments
• Pace may be fast and job completion demands may be high
• While performing the duties the employee is frequently required to sit, stand, walk, and reach with hands and arms; stoop, kneel, crouch or crawl; and see, talk, and hear. The employee must occasionally lift or move up to 50 pounds. Specific vision abilities required by this job include close vision

Note: This job description is not totally inclusive, nor it is designed to cover or contain a complete comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.