Coordinates and assists in maintaining an efficient, timely, and cost-effective production line focusing on real time document review, coordination of resources, and troubleshooting.
The expectations of responsibilities for this position are the following:
- Line Turn Management – Responsible for ensuring line turns are performed on time according to the standards set in place for each specific line.
- First point of contact - responsible for initial communication of issues on production line to ensure proper urgency is taken for resolution. Expectation is to escalate immediately in the event the issue cannot be resolved.
- Cover the line during breaks - Responsible for ensuring the line is producing at the highest optimal level by covering breaks and lunches, as necessary.
- Role Delegation - Responsible for assignment of duties/activities performed on the line
- Material Management - Responsible for managing materials needed on shift ensuring no downtime due to components not readily available and/or reconciled.
- Documentation Verification - Responsible for verification of documentation required for current and next run on production line. Ensuring the document is the current effective document needed for production.
- On the Shop Floor – Expectation to be present 90% of the time on the floor
- FMS Management (If applicable) - Responsible for ensuring FMS is acknowledged and proper steps are taken in the event of an excursion per applicable SOP guidance.
- Assumes other duties and responsibilities, as necessary, within the Packaging department, in an effort to provide the required support to ensure adherence to the production schedule.
- Accountable for assigned production line(s) Labor Utilization, Material Loss, Safety.
- Perform real time document review, facilitate labor by coordinating/ facilitating breaks and line turns, and ensure materials for subsequent batches are available.
- Coordinates, writes and/or circulates for approval all documentation applicable to the production of filled products that are manufactured, packaged, tested and inspected at the Waco site in compliance with Standard Operating Procedures and current Good Manufacturing Practices.
- Developing trend lines and conducting data analyses of production issues related to effective and efficient operation of production process.
- Perform other duties as assigned.
Incumbent has full authority to make decisions and/or take action that is required to carry out job duties. Internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives. The incumbent must be willing to take temporary assignments as required.
Regulated Responsibilities (including cGMP and EHS)
Incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.
Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.
Education and Experience:
Minimum of two (2) years employment experience.
User knowledge of Microsoft Office and SAP transactions strongly preferred.
Working knowledge of cGMP’s and ISO 9002 familiarization and experience working in a GMP regulated environment preferred.
Essential Knowledge, Skills & Abilities:
- Ability to comprehend and implement cleanliness procedures.
- Able to work in confined controlled environment and function effectively as a team member.
- Able to identify labor needs and direct utilization of labor available.
- Able to use initiative in problem-solving and line operation.
- Detail-oriented, highly motivated and able to work under limited supervision.
- Excellent hand-eye coordination and manual dexterity.
- Excellent math skills: ability to add, subtract, multiply, and divide.
- Ability to read, comprehend, write, and communicate effectively in English.
- Ability to carry out detailed written or oral instructions.
- Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
- User knowledge and understanding of Windows based computer systems such as Microsoft Office, with an ability to learn other computer-based systems.
- Ability to work any shift (up to 12-hours) as required dependent on business needs.
- Physically able to continuously stand and walk.
- Physically able to lift up to 40 lbs. for men and 35 lbs. for women.
- Physically able to bend, climb, lift, squat, stoop, and stretch to reach frequently.
Significant Work Activities: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced