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QA Inspector - 3rd shiftSharp Corporation • Conshohocken, Pennsylvania, United States
Postuler Maintenant
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QA Inspector - 3rd shift

Sharp Corporation
  • US
    Conshohocken, Pennsylvania, United States
  • US
    Conshohocken, Pennsylvania, United States
Postuler Maintenant

À propos

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
Ensure and enforce GMP compliance (gowning attire, personnel hygiene, handling/storage of materials, good documentation practices) throughout the production floor.
Verification of documentation, room identification, equipment and incoming components to a packaging room:
Documentation: Ensure all batch record documentation is accurate (lot numbers, expiration dates, item numbers, AQL Report, etc.) 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: Ensure 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 (lot number, expiration date, description, item number, quantity) against Work Order, CoA/CoC, Component Receipt/Return Form and any other supporting documentation. 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.
PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE
Associate or bachelor’s degree preferred, or a high school diploma with at least one to two years of related experience and/or training.
Experience in inspection of pharmaceutical or related industry desired.
General knowledge of FDA regulations related to cGMPs desired.
General knowledge of quality control/assurance desired.
Good documentation and communication skills required.
Good organizational and planning skills required.
SUPERVISORY RESPONSIBILITIES None.
PHYSICAL DEMANDS
Use hands to handle or write and to speak and hear.
Stand, walk and reach with hands and arms frequently.
Occasionally lift or move up to 20 pounds.
May be subject to mandatory overtime if scheduling requires.
Specific vision abilities required include close vision, distance vision, and ability to adjust focus.
WORK ENVIRONMENT Work environment is clean and not normally subject to hazardous conditions. Employees normally stand for long periods of time within a production room.
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  • Conshohocken, Pennsylvania, United States

Compétences linguistiques

  • English
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