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Form of workJob Description
Renaissance LLC
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
Overview
Coordinate the daily activities on a line, directing staff assigned to that area, contacting maintenance as needed and working with the QA inspectors to efficiently produce product in compliance with the batch record and all applicable SOPs. Assure the proper loading, tracking and recording of product components required in the operation of the line equipment. Perform pre and post cleaning functions of the operating equipment, supporting equipment and work areas. Perform all documentation that is required as part of the production line operations including material/component tracking, reconciliation, product testing, line set up, line clearance and cleaning. Perform testing and inspection of product to meet product specifications. Perform as an Operator 1, Operator 2, Stock Person or Assembler as required for brief periods of time, function as a relief person. Assure that products are manufactured according to SOPs and in a cGMP compliant manner.
This is a union position with a non negotiable pay rate.
Responsibilities
1. During manufacturing operations coordinate all activities of the line equipment and Operators, typically equipment for forming, filling, closing, labeling and packaging of the product, as defined in related SOPs, work instructions and the Fill and Package Record.
2. Ensure that all equipment and the manufacturing area are kept clean during the course of normal operations, at the end of the shift, and as assigned otherwise. Document cleaning as required.
3. Ensure that all documentation is performed according to required frequency, completed in a timely manner, is accurate and neat and conforms to cGMP requirements. Responsible for completeness of all documentation that is associated with the packaging of product, including the recording of downtime and calculation of throughput figures and percentages.
4. Ensure that all required product testing and inspection is performed according to the appropriate SOP and/or Fill and Package Record. Any deviations are communicated and recorded as required by the related SOP and/or Fill and Package Record. Perform tests to support other Operators.
5. In the performance of daily activities, ensure that safe work practices are employed. Address and report any observations of unsafe behavior or practices immediately and any recommendations for safety improvements to the Supervisor.
6. Ensure that in the performance of daily activities, that all applicable cGMP are employed. Immediately address and report to Quality Assurance and the Production Supervisor any behavior or practice that is not cGMP compliant. Maintain knowledge of cGMP by attending required training sessions. Share operational knowledge with peers, new-hires, contingency staff members, and newly-appointed operators, as needed, to maintain efficiencies and cGMP compliance.
7. Assume the lead role in line clearance and set up activities as defined in the related SOPs and Fill and Package Records. These activities include as examples, equipment set up, code set up, product inspections, component verification, cleaning, reconciliation, component and material removal and documentation.
8. Assure that assigned lines are started in a timely manner, employees leave and return from breaks in a timely manner and that shift requirements for production and quality are met. Participate in team efforts to improve labor reporting accuracy and our work environment, product quality, efficiencies, and other initiatives identified as being beneficial to our business.
9. Exemplify Renaissance Core Values.
Qualifications
High school degree, with a minimum of 2 years of relevant mechanical experience; or equivalent combination of advanced education (ie, coursework in Life Sciences) and experience.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
Overview
Coordinate the daily activities on a line, directing staff assigned to that area, contacting maintenance as needed and working with the QA inspectors to efficiently produce product in compliance with the batch record and all applicable SOPs. Assure the proper loading, tracking and recording of product components required in the operation of the line equipment. Perform pre and post cleaning functions of the operating equipment, supporting equipment and work areas. Perform all documentation that is required as part of the production line operations including material/component tracking, reconciliation, product testing, line set up, line clearance and cleaning. Perform testing and inspection of product to meet product specifications. Perform as an Operator 1, Operator 2, Stock Person or Assembler as required for brief periods of time, function as a relief person. Assure that products are manufactured according to SOPs and in a cGMP compliant manner.
This is a union position with a non negotiable pay rate.
Responsibilities
1. During manufacturing operations coordinate all activities of the line equipment and Operators, typically equipment for forming, filling, closing, labeling and packaging of the product, as defined in related SOPs, work instructions and the Fill and Package Record.
2. Ensure that all equipment and the manufacturing area are kept clean during the course of normal operations, at the end of the shift, and as assigned otherwise. Document cleaning as required.
3. Ensure that all documentation is performed according to required frequency, completed in a timely manner, is accurate and neat and conforms to cGMP requirements. Responsible for completeness of all documentation that is associated with the packaging of product, including the recording of downtime and calculation of throughput figures and percentages.
4. Ensure that all required product testing and inspection is performed according to the appropriate SOP and/or Fill and Package Record. Any deviations are communicated and recorded as required by the related SOP and/or Fill and Package Record. Perform tests to support other Operators.
5. In the performance of daily activities, ensure that safe work practices are employed. Address and report any observations of unsafe behavior or practices immediately and any recommendations for safety improvements to the Supervisor.
6. Ensure that in the performance of daily activities, that all applicable cGMP are employed. Immediately address and report to Quality Assurance and the Production Supervisor any behavior or practice that is not cGMP compliant. Maintain knowledge of cGMP by attending required training sessions. Share operational knowledge with peers, new-hires, contingency staff members, and newly-appointed operators, as needed, to maintain efficiencies and cGMP compliance.
7. Assume the lead role in line clearance and set up activities as defined in the related SOPs and Fill and Package Records. These activities include as examples, equipment set up, code set up, product inspections, component verification, cleaning, reconciliation, component and material removal and documentation.
8. Assure that assigned lines are started in a timely manner, employees leave and return from breaks in a timely manner and that shift requirements for production and quality are met. Participate in team efforts to improve labor reporting accuracy and our work environment, product quality, efficiencies, and other initiatives identified as being beneficial to our business.
9. Exemplify Renaissance Core Values.
Qualifications
High school degree, with a minimum of 2 years of relevant mechanical experience; or equivalent combination of advanced education (ie, coursework in Life Sciences) and experience.
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