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QA Inspector

Conshohocken, PA 19428

Posted: 04/01/2023 Job Number: 30332

Job Description

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


·       Responsible to  ensure and enforce GMP compliance (including but not limited to:  gowning attire, personnel hygiene, handling/storage of materials and good documentation practices) throughout GMP facility areas.

·       Responsible to  ensure the packaging record is being executed by all associates  according to the process steps.

·       Responsible for  documentation, room identification, equipment and components  as follows:


·       Ensure packaging record documentation is accurate (lot numbers, expiration dates, items number, equipment asset numbers, equipment calibration dates) and related data are consistent throughout the record;  ensure AQL Report is accurate  and complete, and error corrections are made according to GDP in a timely manner.

·       Read and  understand process steps within the packaging record  to ensure compliance during the packaging process.

·       Review packaging record and corresponding documentation  for additional requests, memos, deviations, change controls, etc.

·       Ensure  room/equipment cleaning logs have been completed  as applicable.

·       Ensure  room identification information matches packaging record.

·       Review packaging record for accuracy, legibility, traceability and accountability at the end of each shift or lot, whichever is first.


·       Verify equipment asset numbers.

·       Ensure equipment listed in the process is listed on the equipment verification pages and all applicable challenges are in the packaging record.

·       Verify that calibrated equipment is appropriately labeled  and within calibration date.


·       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 packaging record.

·       Responsible for packaging record approval including AQL Sampling Plan calculation and/or verification and verification of label and pallet tag information prior to delivery to production room.

·       Responsible for  packaging record, component and equipment staging in production room.

·       Responsible for verification of room cleans including proper completion of corresponding logbooks.

·       Responsible for performing quality inspections as required per the packaging record and per AQL requirements, verification of challenges and collecting samples as required.   Inspections may include visual, functional, destructive and count checks.

·       Responsible for transaction and reconciliation verification.

·       Responsible for  periodic review of logbooks  for completeness and accuracy.

·       Responsible for training quality inspectors.

·       Responsible for participating in continuous improvement projects. 



An Associate’ s or  Bachelor’ s degree is preferred. A High School Diploma with (3) years related experience and/or training is required in lieu of a degree.  Experience with inspection of pharmaceuticals or related industry is desired.

·       General knowledge of FDA regulations related to cGMP is desired.

·       General knowledge of quality control/assurance is desired.

·       Good documentation and communication skills are required.

·       Good organizational and planning skills are required. 

Ability to apply moderately complex mathematical operations to assigned tasks is required; this includes an understanding of statistical sampling plans, and the ability to calculate time, percentages and decimals.   Basic math skills (addition, subtraction, multiplication and division) are required. 

Ability to effectively communicate written and verbally is required. Communication includes but is not limited to the following:


·       Internal – Daily contact with Quality and Operations departments related to Quality and cGMP.

·       External - Infrequent contact with customer representatives related to quality inspections.

WRITTEN SKILLS:  The ability to provide clear, concise and legible documentation within batch records, forms, and/or memos to file in conformance with basic Good Documentation Practices is required. 

COMPUTER SKILLS:  Working knowledge of basic Windows applications including Lotus Notes (e-mail) and Microsoft Office programs is required.

Meet Your Recruiter

Lauren Adams

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