Quality Unit Associate

Company Overview:

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. Come join the Keystone team so we can build your career together!

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

Please visit our website at www.keystoneind.com to learn more about Keystone Industries and career opportunities.

Position Details:

• Title: Quality Unit Associate 
• Ideal Candidate: The ideal candidate is a detail-oriented and safety-conscious quality professional with hands-on experience in cGMP environments, strong knowledge of FDA regulations, excellent organizational and communication skills, and the physical capability to work in diverse manufacturing settings.
• Schedule: 1st shift: 7:00am - 3:30pm, Monday - Friday
• Location: Gibbstown, NJ (08027)

Essential Job Functions:

• Approve or reject for use, all incoming drug, medical device and other components, containers, closures, packaging materials and labels, according to defined requirements.
• Physically sample and 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. (i.e: 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, medical device and other 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 and quality of other 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.
• Work safely with chemicals.
• Perform job functions within a cleanroom environment while adhering to applicable guidelines and gowning requirements.

Qualifications:

• Experience performing cGMP regulatory or quality assurance duties or appropriate on-the-job training.
• Demonstrated knowledge of, or training to, FDA CFR 210, 211, and 820 cGMP requirements.
• Strong 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 Office.
• Capable of handling hazardous chemicals.
• High attention to detail.
• Strong organizational skills.

Education/Certifications:

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

Safety:

• Complies with all safety regulations; maintains a safe work environment at all times.
• Adheres to always wearing the proper PPE/Safety equipment.
• Understands and complies with all written safety, health, and environmental procedures.
• Attends all required scheduled Health, Safety and Environmental training sessions.
• Participat