QA Line Inspector
Company: Renaissance LLC
Posted on: November 23, 2020
Renaissance LLCAll 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.
Quality Assurance Inspectors work "hands-on" on the production
floor, inspecting packaging, labeling and finished products to
ensure products comply with Company policies and standard operating
procedures (SOPs) and Good Manufacturing Practices (GMP)
requirements. Quality Assurance Inspectors perform sampling,
inspection and physical testing of packaging components. They issue
and control the labels and packaging inserts and are responsible
for following all quality assurance procedures and ensuring all
documentation meets cGMP standards.
- Perform Quality Assurance tasks including production line
clearances, sampling, inspections, and quality attributes testing
- Monitor product quality through the performance of required
visual testing A brief description of the job's primary purpose or
contribution to the department or organization
- Perform routine line clearances/in-process inspections on the
packaging lines and compounding suites.
- Ensure routine compliance of day to day activities on the
compounding and packaging areas; working with operations personnel
to achieve compliance.
- Monitor packaging and compounding to ensure that batch
documentation requirements and SOPs are being followed.
- Review the required paperwork for accuracy and compliance, both
on line and upon completion of the activity.
- Ability to gown to Grade C standards and perform quality
inspection inside cleanroom areas.
- Report non-conformances associated with components, in-process
materials, finished products, etc. that may be identified at any
stage of production or storage.
- Collect representative samples for testing and retention, and
ensure all relevant paperwork is complete. Submit samples/resamples
to laboratory in a timely fashion to meet production needs.
- Inspect and approve packaging components,
manufacturing/packaging rooms, lines and equipment prior to
- Sample in-process items and finished products. Perform required
inspections and testing of in-process items and finished
- Apply disposition stickers to components, in-process materials
and finished products.
- Stage label and inserts on production lines, issuing reports
and verifying customer and Renaissance part numbers and comparing
information to the staging sheet. Return unused labels and inserts
or have them destroyed when requested by customer.
- Process and distribute samples to other teams (i.e. Quality
Control Laboratory) for evaluation and testing, as required.
- Review records to confirm accuracy, completeness and GMP
- Ensure all work performed is documented accurately and
completely in batch records, forms, logs and other documents.
- Provide training to QA and Operations staff on proper
documentation and inspection procedures.
- Maintain a clean and safe environment in compliance with State
and Federal regulatory guidelines.
- Ability to work with computer based systems and equipment.
- Perform other duties and responsibilities as assigned
High School diploma or GED and a minimum of 3 years of relevant
experience or equivalent combination of education and
Keywords: Renaissance LLC, Lakewood , QA Line Inspector, Other , Lakewood, New Jersey
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