The Encapsulation Operator is responsible for the operation and set-up of automatic capsule filling machine in accordance with company standard operating procedures (SOPs) and cGMP regulations to ensure products meet applicable quality standards. This position includes set-up, operation, cleaning and light mechanical adjustments. The Encapsulation Operator is accountable for overall production line performance including safety, quality, shrink, attainment and line efficiency. Operators must be capable of operating multiple like machines at one time and learning to operate a variety of equipment within the manufacturing area.
Essential Job Functions
- Perform machine cleaning, changeovers and set up as required while maintaining a clean working environment.
- Ensures full compliance with Company policies, procedures, GMP’s, Ethical Business Practice, and SOP’s at all times. Ensures documentation such as operation logs, batch records, etc. are fully completed, signed and in compliance with company standards and regulatory requirements.
- Utilizes problem-solving skills to investigate and troubleshoot product issues and recommend solutions for: 1) encapsulation issues such as denting, splitting, capsule not entering the magazine or rectifier block, capsule not getting loaded, capsule non-separation, target weight not achieved or weight variation, not closing properly 2) general issues such as machine set-up, machine performance, and documentation
- Ensures that product meet applicable quality standards. This includes inspection for quality during operation and performing all required sampling and testing.
- Perform start-ups and reconciliation before, during, and after batch is completed.
- Takes samples of product and perform in process testing as per batch record instructions.
- Review batch records for accuracy and completeness, correctly documenting all steps.
- Observe machine operation; makes adjustments as needed; inspect machine for wear and tear and report any issues to supervisor.
- Inform supervisor/manager of any discrepancies during production and stop production and segregate product not in compliance.
- Coordinate with supervisor to enhance productivity and quality
- Perform all material handling of product and components.
- Train new encapsulation workers on SOP’s, cGMP’s, and the operation of processing equipment from start to finish.
- Participate in any investigation for a deviation involving a batch record.
- Maintain proper gowning and hygiene to ensure integrity of the product as per cGMP’s, and ensure that all other safety standards are in place.
- Fill in appropriate logbook for equipment and rooms.
- Perform processing room cleaning as needed.
- Works extended hours and occasional weekend overtime.
- Other duties as assigned
- High school graduate or GED equivalent
- 3+ years Encapsulation Operator experience
- Minimum of one (1) year work experience in nutritionals, supplements, food or pharmaceutical manufacturing industries.
Knowledge, Skills & Abilities:
- Demonstrates ability to work in a team and assist others.
- Able to follow written instructions precisely and perform basic math calculations as required.
- Attention to detail and accuracy with numbers.
- Understands and is knowledgeable of cGMP, OSHA standards etc.
- Mechanically inclined to understand inner workings of equipment.
- Demonstrates the ability to read and write basic English in order to be able to understand the industry regulated instruction sheets.