QA Inspector Level I (3rd Shift)

Sharp Services•Conshohocken, PA

10d•Onsite

About The Position

Responsibilities include adherence to and enforcement of GMP compliance, performing inspections of components, bulk product, work-in-process and finished goods related to contract packaging, reviewing documentation and verification of component attributes. The impact of the quality inspection process directly impacts company compliance to regulatory requirements and customer satisfaction.

Requirements

Good documentation and communication skills are required.
Good organizational and planning skills are required.

Nice To Haves

Associate or bachelor’s degree is preferred or a High School Degree with at least one to two years’ related experience and/or training.
Experience in inspection of pharmaceutical or related industry is desired.
General knowledge of FDA regulations related to cGMPs is desired.
General knowledge of quality control/assurance is desired.

Responsibilities

Ensure and enforce GMP compliance (including but not limited to gowning attire, personnel hygiene, handling/storage of materials and good documentation practices) throughout the production floor.
Verify documentation, room identification, equipment and incoming components to a packaging room.
Ensure all batch record documentation is accurate (lot numbers, expiration dates, items number and related data are consistent throughout the record; AQL Report is accurate), and complete.
Read and understand process steps within the batch record to ensure compliance during the packaging procedure.
Review batch record for any additional requests, memos, deviations, change controls, etc.
Ensure room/equipment cleaning logs have been completed as applicable.
Verify that Room Identification information matches batch record.
Ensure all asset numbers are documented appropriately in the batch record.
Ensure all equipment listed in the process is listed on the equipment verification pages and all applicable challenges are in the batch record.
Ensure all calibrated equipment is labeled and within the appropriate calibration window.
Verify each component’s attributes (at minimum – lot number, expiration date, description, item number and quantity) against Work Order, CoA/CoC, Component Receipt/Return Form and any other supporting documentation within the batch record.
Verify challenges were performed according to SOP and batch record requirements.
Pull and identify customers and Sharp retain samples as per batch record requirements.
Ensure batch records are being executed by all associates according to the process steps.
Review batch record for accuracy, legibility, traceability and accountability at the end of each shift or lot, whichever is first.