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Operator I, 2nd shift

Company: Renaissance LLC
Location: Lakewood
Posted on: November 19, 2021

Job 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

Operate line equipment to meet product specifications and production requirements. Assure the proper loading, tracking and recording of product components required in the operation of the line equipment. Perform cleaning functions of the operating equipment, supporting equipment and work areas. Perform 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 2 or Assembly Worker as required. Assure that products are manufactured according to SOPs and in a cGMP compliant manner.

Responsibilities

During manufacturing operations operate packaging equipment typically equipment for forming, filling, closing and labeling filled packages, as defined in related SOPs, work instructions and the Fill and Package Record. This equipment may include monoblock fillers, form and fill equipment, bottle/vial/tube fillers, cappers, pump placers, stoppering and torque units, labelers, and dose cup placers.
Ensure that all equipment and the manufacturing area is kept clean during the course of normal operations, at the end of the shift, and as assigned otherwise. Document cleaning as required.
Ensure that all documentation is performed according to required frequency, completed in a timely manner, is accurate and neat and conforms to cGMP requirements.
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.
In the performance of daily activities, ensure that safe work practices are employed. Report any observations of unsafe behavior or practices immediately and any recommendations for safety improvements to the Line Leader and/or Supervisor.
Ensure that in the performance of daily activities, that all applicable cGMP are employed. Immediately report to the Line Leader, Quality Assurance or the Production Supervisor any behavior or practice that is not cGMP compliant. Maintain knowledge of cGMP by attending required training sessions.
Actively participate 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, product inspections, component verification, cleaning, reconciliation, component and material removal and documentation.
Participate in team efforts to improve our work environment, product quality, efficiencies, and other initiatives identified as being beneficial to our business.
Exemplify the DPT Core Values of Integrity, Dignity, Perseverance and Trust
Within my areas of responsibility, understand and comply with all DPT safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations.
Follow instructions given by the Supervisor or area Line Leader.

Qualifications

High school degree, with a minimum of 3 years of relevant experience; or equivalent combination of advanced education (ie, coursework in Life Sciences) and experience.

PI152092275

Keywords: Renaissance LLC, Lakewood , Operator I, 2nd shift, Other , Lakewood, New Jersey

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