ESSENTIAL DUTIES AND RESPONSIBILITIES (other duties may be assigned)
Able to perform all requirements of Production Operator II and Production Operator II Tech (aka Production Tech).
Perform lot release functions at the Work Center.
Detailed on-the-job Operator Training.
In-person training on production documents (WI, IP, QA…etc.)
New Operator: onboarding, introduction to Production, and training on all points related to Operator job description.
New Job, including daily assignments.
New Work Order and related requirements.
Evaluation of Operator performance and mentor as needed.
Provide support to Production Operator II Tech position.
Back up Supervisor and Production Operator II Tech as needed.
Audit work centers daily for problem areas and additional on the job training needs.
Verify production job-related documents to confirm information/requirements are aligned.
Review of WO’s for completeness for all shifts as well as completing the checklist at the end of the WO’s (including accurate / completion of cycle cards for molding and secondary operations).
Perform dispositioning of shift production WO’s for the shift being supported.
Audit of WI’s as used in on-the-job training, suggesting modifications as needed.
Audit of Master Cycle requirements and inputs to follow validated job parameters.
Understanding of tool and press plumbing to ensure proper setup and manufacture of conforming product.
Assist Material Handler to ensure materials are scanned, dispositioned, and reconciled appropriately.
Ensure labelling on bottles and other containers are legible and adequate. (example: containers of Isopropyl Alcohol)
Add any support necessary to the assigned shift (help Production Operator II Tech if workload warrants, help Inspector with visual inspection of product,).
Participation with the Comar team in the development of TWI (Training Within Industry) work instructions training break downs.
Knowledge of production document change / approval process.
Communicate problems to Process Technician or Supervisor.
Maintain a clean and safe work environment.
Adhere to and communicate to others all plant Health, Safety and Quality guidelines and GMP.
Must be aware of the location and purpose of the quality procedures and quality manual.
PERSONNEL SUPERVISED
None during normal schedule. Those reporting to Supervisor when backing up.
QUALIFICATIONS
To perform this position function successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION & EXPERIENCE
· High school diploma or general education degree (GED).
Preferred:
· 1 years’ experience as Production Operator.
· Experience in secondary operations, lot release and Production Operator II Tech duties.
· Additional education in related vo-tech, operations or manufacturing field.
· Prior experience in ISO13485 manufacturing environment.
SKILLS-ABILITIES
· Log in to IQ and enter production data and complete production forms (batch records).
· Must thoroughly understand the process of manufacturing, packaging, and labeling product.
· Read, understand, and follow documents such as safety rules, operating & maintenance instructions, and procedures.
· Apply basic math skills: add, subtract, multiply, and divide.
· Utilize and carry out instructions provided in written, oral, or visual/diagram form.
· Self-motivated, conscientious, with a results-oriented mindset.
· Good organizational and communication skills to work independently and in a team environment.
· Ability to use measuring devices and test equipment such as Caliper, Micrometers, Gage Blocks, Pin Gages, Vision System, Dial indicator, Go/No Go gauges.
· Ability to work in a fast-paced manufacturing environment with demonstrated ability to handle and prioritize multiple tasks and demands.
· Strong technical aptitude, as well as analytical and problem-solving skills to trouble shoot and solve problems.
· Sound judgment - ability to work efficiently with many competing demands.
· Ability to communicate their job-related functions with other employees, customers and auditors as needed.
· Ability to frequently sit, stand, walk, bend, and occasionally lift or move up to fifty pounds.
· Required vision abilities include close vision, distance vision, color vision and the ability to adjust focus.
