Responsible for the preparation and/or operation of various components, materials, equipment, machines including, but not limited to any and/or all applicable components, materials, equipment, machines in the assigned area(s). Performs all tasks in accordance with GMP’s and department SOP’s, to maintain product integrity and quality standards.
This position is responsible for the following:
- Perform tasks in the production/packaging of product to provide on-time delivery to customers.
- Assist Maintenance Technicians with basic mechanical adjustments as needed.
- Perform set-up and changeovers on production / packaging equipment.
- Troubleshoot equipment and coordinate corrective actions to reduce or eliminate defects, rejects, or equipment downtime.
- Complete all required documentation associated with the production and / or packaging of product.
- Assist daily production in operating and monitoring technical, computerized, production machinery, ensuring quality standards are maintained.
- Maintain a clean and organized work area during and at the end of each shift.
- Assist in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies.
- Perform all assigned duties according to departmental SOP’s and cGMP’s.
- Remain current on proper procedures by reviewing current, revised, and new SOP’s relating to the job and to the department.
- Complete and remain current with all required cGMP and safety training.
- 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 requirements for this position are:
High School Diploma or GED equivalent required.
Two (2) years of experience working with high speed production lines and mechanical experience preferred.
Experience working in a GMP regulated environment preferred.
Experience working in an Aseptic Production environment preferred.
Essential Knowledge, Skills & Abilities:
- Ability to gown aseptically and retain certification.
- Ability to comprehend and implement good housekeeping procedures.
- Ability to work in a confined and controlled environment.
- Ability to do basic mechanical set-ups, troubleshooting and repairs.
- Ability to understand and follow machine operation manuals.
- Fast learner and the ability to teach and transfer knowledge to others.
- Detail-oriented and self-motivated
- 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 verbal instructions.
- Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
- Basic 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.
- Ability to use, clean, and store tools and other devices required for the performance of the job in a manner which prevents damage to the tools and / or equipment.
*sign-on bonus for external candidates only to be paid out after 60 days of employment
Significant Work Activities: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced