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Quality Inspector (Pharmaceutical Production)

Company:

Keystone Industries is an exciting and rewarding place to work. We are passionate about our employees. We strive to create an environment that is stimulating and motivating and a culture that fosters mutual respect, teamwork and career development. Please visit our website at www.keystoneind.com to learn more information about Keystone Industries and career opportunities.

In addition to competitive starting salaries, we offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. See company benefits below.

Keystone Industries is currently seeking a  Quality Unit Associate/Quality Inspector for our Pharma Division. This position is 1st shift (M-F, 7 AM – 330 PM), and located in Gibbstown, NJ (480 S. Democrat Road, Gibbstown, NJ 08027).

This position is in a pharmaceutical/production setting and requires strong attention to detail and computer skills. The individual will work in both an office completing documentation and on the production floor conducting quality checks. The ideal candidate will have exceptional interpersonal skills, with the ability to interface and communicate/collaborate at all levels internally and externally.

Position Overview:

Perform quality unit activities as required by FDA 21CFR Parts 210/211, including the following, as well as performing other quality system responsibilities, as needed.

Essential Job Functions:

  • Approve or reject for use, all incoming drug components, drug product containers, closures, packaging materials and labels, according to defined requirements.
  • Coordinate the sample collection, labeling, QC testing and sample retain of all raw materials and final drug products. Ensure appropriate status identification and storage of all materials. (ie: quarantine vs. approved).
  • Perform / assist with daily label control system responsibilities, including, but not limited to setting up label specification sheets, inventory control forms, label issuance, reconciliation, inventory and proper storage.
  • Perform inspections and release of equipment and process areas before use to ensure they are clean and do not contain previous products or packaging/ labeling supplies.
  • Perform batch quality control activities, such as sample submission to quality control laboratory, review of final test reports, and stability studies.
  • Place on hold in-process materials suspected of being nonconforming pending disposition.
  • Assist in the review of drug production and packaging records for complete-ness and to ensure no errors have occurred. If errors have occurred, the quality unit is responsible to ensure errors are fully investigated and corrective action/product disposition is appropriate.
  • Assist with the documentation of procedures or specifications impacting the identity, strength, quality, and purity of drug products. Ensure procedures are appropriate, implemented and consistently followed. Ensure any deviations from established procedures are recorded and justified.
  • Ensure controls are appropriate and followed to protect product, labels, and supplies from possible loss, mix-up, or contamination.
  • Ensure the proper maintenance of all records and sample retains according to regulatory requirements.
  • Perform or assist with all aspects of the Quality Management System: such as corrective/preventive actions, conformance investigation, technical documentation, production reports, regulatory paperwork, deviations, internal audits, validation, and training.

Qualifications:

  • Experience performing cGMP regulatory or quality assurance duties or appropriate on-the-job training to them required
  • Demonstrated knowledge of, or training to, FDA CFR 210 & 211 cGMP requirements
  • Exceptional interpersonal skills-ability to interface and communicate/collaborate at all levels internally and externally
  • Strong verbal and written communication skills
  • Computer literate; familiarity with Microsoft outlook, word and excel
  • Capable of occasionally lifting 40 pounds
  • Capable of handling hazardous chemicals
  • High attention to detail
  • Exceptional project management and organizational skills

On the Job Training:

  • See the training needs form for this position

Education/Certifications:

  • High School diploma or equivalent and/or equivalent work experience. Some college education preferred

To apply for this job email your resume in Word or PDF format to careers@keystoneind.com

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