Operator I, 2nd shift
Company: Renaissance LLC
Posted on: November 19, 2021
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.
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
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
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
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.
Keywords: Renaissance LLC, Lakewood , Operator I, 2nd shift, Other , Lakewood, New Jersey
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