- Job Title
- QS Associate
- Job ID
- Lakewood, NJ
- Other Location
QS Associate, Lakewood, NJ
Basic Job Functions:
Perform sampling and inspection of packaging components using standard inspection techniques and methodology. Sample raw materials and bulks to specific amounts that conform to the customer’s specification in a manner that complies with Accupac’s Standard Operating Procedures and the FDA’s Good Manufacturing Practice regulations.
Essential Functions of the Job:
- Perform functional and aesthetic inspection on incoming packaging components per approved Accupac SOPs, and customer specifications.
- Advice the QA Incoming Supervisor/QA Management of non-conforming components found during incoming inspection.
- Create, review and approve component Material Assay Reports. Revise as necessary.
- Read, comprehend and interpret written instructions in order to obtain raw materials in quantities that conform to customer specifications.
- Identify raw material sampling issues when they arise and notify QA Incoming Supervisor and/or QA appropriate personnel of such issues.
- Clean and maintain the raw material sampling suites according to established housekeeping procedures.
- Review and understand Standard Operating Procedures
- Organize and maintain QA document storage areas
- Maintain raw material and finished goods reserve sample storage area.
- Ensure that measuring devices used for incoming inspections are calibrated according to established Standard Operating Procedures.
- Support the stability program by setting up materials in the stability chambers and pulling samples from the stability chambers at predefined times as defined by an approved stability protocol.
- Assist with temperature and humidity monitoring of stability chambers and specified warehouse locations.
- Assist with Sampling/Inspection training.
- Interact with the Project Management and Purchasing groups to keep them apprised of issues that arise during incoming component inspections and raw material sampling.
- Perform other duties as assigned.
Minimum Requirements of the Job:
- Experience working in an environment that functions under cGMPs.
- Ability to work independently from an established list of priorities.
- Ability to lift up to 50 lbs.
- Ability to push and/or pull item 75 to 100 pounds.
- Possess peripheral and color vision.
- Walking/standing on concrete floors up to eight hours each workday.
- Climbing step stools and ladders and maintaining balance.
- Required Skills