Inspector; QA Packaging - 2nd Shift (4:30PM - 1:00AM)

CONTRACT PHARMACAL CORP•Town of Smithtown, NY

11d

About The Position

The QA Packaging Inspector inspects documentation records, products, facilities, and equipment before, during, and after packaging runs. The role works in production operations facilities and requires compliance with cGMP requirements, applicable company policies, and related SOPs. The position has no supervisory responsibilities. Gowning is required as specified by GMPs and/or SOPs, and PPE is used as needed. Work hours, shifts, and work locations may change based on business needs and management discretion.

Requirements

High school diploma or GED required; college education is a plus.
Ability to perform basic math.
Knowledge of Microsoft Office programs.
Excellent organizational skills and attention to detail.
Ability to reach, write, and communicate effectively.
Ability to use hands and fingers to handle or feel objects and tools; stoop, kneel, crouch, stand, bend, sit, talk, hear, and climb stairs and ladders.
Ability to lift and/or move up to 50 pounds.

Nice To Haves

Work experience in a quality assurance or GMP environment is preferred.
College education is a plus.

Responsibilities

Verify line cleaning and approve line release on a timely basis.
Monitor packaging and inspection operations for conformance to specifications and procedures.
Sample packaged product for QC testing, stability, or as required by the packaging record.
Complete packaging logbooks, recording required information neatly and accurately, and verify that operations-entered data is neat, complete, and accurate.
Perform and verify documentation for packaging qualification.
Maintain house standards and compare product for physical verification.
Communicate with production personnel about availability for line cleaning and line release approval, as well as product- or equipment-related quality issues.
Review packaging documentation.
Inspect final finished packages before the end of the packaging run and before transfer to the warehouse.
Notify QA management of quality or safety concerns.
Apply knowledge of cGMPs related to US FDA manufacturing and packaging environments.
Comply with applicable company policies, including cGMP and related SOPs.
Comply with safety rules and regulations and lead by example in promoting safety and health.
Perform other responsibilities as assigned by senior management.