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 an employee encounters while performing 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.