Quality Assurance Inspector (Locals ONLY)

Impax Laboratories, Inc. is a technology based specialty Pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products.

 

Job Summary:  The QA Inspector has the responsibility to sample, inspect and evaluate incoming materials for disposition based on cGMP directives and SOP policy; monitor and provide support to the Packaging operation.  The Inspectorate Group directly provides functional and compliance oversight to Operations and supports other programs such as returned goods, customer complaints, and retain sample inspection.

 Responsibilities:Operations Involvement

·  Sample and inspect all packaging components, bulk and finished product (where appropriate) for final disposition based on defined sampling plans and accept/reject criteria.  Document results in a neat/legible manner.

·  Monitor all aspects of the Packaging operation-line activities, inventory on-line; perform line checks such as closure torque, dosage counts, etc.

·  Complete the documentation to transfer materials from the different stages, eg, quarantine to Release to Reject and sticker materials accordingly.

·  Provide sufficient labeling to Packaging to fulfill an order; inventory the amounts.

·  Assist in the rejection of materials; prepare Rejection and MDO documents.Special Projects

·  Returned Goods—Document and inventory the items received.

·  Calibrate equipment used in the performance of duties.

·  As needed, assist in the monitoring/ implementation aspects of cleaning validation, IQ/OQ/PQs.

·  Assist as required with the Customer Complaint program and Retain Sample Inspection.

·  Participate in the company-wide cGMP training program and SOP training.

·  QC—Forward finished product samples to either Impax, CA or third-parties for initiation of stability studies; forward retain samples as appropriate.

·  There are no direct reports.  An Inspector with demonstrated proficiency in a certain area may train other inspection or other personnel.

 



Job Requirements:

·  2-3 years experience in the pharmaceutical industry, preferably one year in QA. 

·  Working knowledge of GMPs.

·  High school diploma; an Associates degree or some college-level training in one of the sciences is a plus. 

·  Self-starter with good communication skills.