QA Inspector Level I (3rd Shift)

Sharp Services, LLC; Conshohocken, Northern (Montgomery County, KY); Hybrid; USD 52,000 - 68,000; Full time

Job summary

Sharp Packaging Services is seeking a QA Inspector Level I to support GMP compliance and packaging operations. The role focuses on enforcing quality standards on the production floor, reviewing batch records, and verifying component attributes to ensure regulatory alignment and product integrity.

Responsibilities include confirming documentation accuracy, room and equipment identification, calibration status, and adherence to SOPs.

Qualifications

• Knowledge of cGMP and cleanroom practices.
• Strong documentation and record-keeping.
• Experience inspecting pharmaceutical components and finished goods.

Responsibilities

• Adhere to GMP compliance on production floor.
• Verify batch records, equipment lists, and component attributes.
• Ensure room identifications and calibration are current.
• Verify incoming components against documentation and CoA/CoC.

Skills

GMP compliance

Documentation review

Inspection operations

Attention to detail

Education

Associate degree

Bachelor's degree

High School Diploma with related experience

Job description

SUMMARY

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The following is a list of minimum responsibilities related to the QA Inspector Level I position. Other duties may also be assigned.

• 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 the production floor.
• Responsible for verification of documentation, room identification, equipment and incoming components to a packaging room as follows:
• Documentation: 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. Room Identification information matches batch record.
• Equipment: All asset numbers are documented appropriately in the batch record. All equipment listed in the process is listed on the equipment verification pages and all applicable challenges are in the batch record. All calibrated equipment is labeled and within the appropriate calibration window.
• Incoming Components: 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.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

SUPERVISORY RESPONSIBILITIES

None

PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE

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

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to handle or write and to speak and hear. The employee frequently is required to stand, walk and reach with hands and arms. The employee must occasionally lift and/or move up to 20 pounds. The employee may be subject to mandatory overtime if scheduling requires. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is normally required to stand for long periods of time within a production room. The working environment is clean and not normally subject to hazardous environment or conditions.

DISCLAIMER

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

Sharp Packaging Services works across the world to create unique commercial and clinical packaging solutions for the pharmaceutical and biotechnology industry. We are made up of two dynamic international divisions, Sharp Packaging Solutions and Sharp Clinical Services. Together our 1,600-strong team works from state-of-the-art facilities in the United States, United Kingdom, Belgium and the Netherlands. We’ve built an exceptional global reputation for the design, serialisation and production of innovative, cost-effective compliance packaging for even the most complex products. Our extensive range includes blister packs, bottles, pouches and stick packs, but our expertise goes far beyond, enabling us to support your product through every stage of design, development, manufacture and delivery. Our clinical services division is one of the world’s leading providers of innovative clinical supply chain services, with a talented and highly experienced team that can handle every aspect of your supply chain. Our work spans everything from drug development and manufacturing to clinical supplies packaging, labelling, distribution, Qualified Person auditing and comparator sourcing.