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Quality Assurance Associate

Quality Assurance Associate

RxSourceNJ, United States
30+ days ago
Job description

At RxSource, our purpose is to improve the lives of patients. We accomplish this by offering Clinical Trial Supply Chain Services and Pharmaceutical Procurement globally. With offices in Canada, the USA, and Ireland, we deliver tailored services to Pharmaceutical Sponsors, Biotechs, and CROs. Our team and culture are our most valuable assets, embodying our core values in everything we do. We see our clients as partners, and their success is our success.

We currently have an opening for a Quality Specialist at our West Deptford, New Jersey facility. This role will lead the Quality function and will have one direct report. If you are a personable and proactive Quality professional with experience in clinical trial packaging and labelling, pharma manufacturing or pharma distribution , we would like to hear from you.

What you will do :

  • Lead the QA function at the New Jersey facility
  • Manage all controlled GMP documents
  • Initiate and handle EQMS reports (i.e. Deviation, CAPA, Change Control, etc.) reports as required
  • Qualify GMP Equipment / Systems / Facilities
  • Ensure all regulatory and quality-related documentation is maintained in accordance with relevant SOPs and regulatory requirements
  • Plan and conduct required Quality training for all employees (i.e. GMP, SOPs, etc.)
  • Provide support for customer and regulatory inspections
  • Conduct supplier and customer verification / qualification and approval

Your qualifications, skills and experience include :

  • 5 or more years in a QA role in CTS or pharma manufacturing / distribution
  • A degree or diploma from a recognized college or university
  • Experience leading and coaching a QA / QC team preferred
  • In depth knowledge of FDA and New Jersey Dept. of Health regulations and guidelines
  • Knowledge of Health Canada regulations preferred
  • Strong written and verbal communication skills
  • Ability to prioritize
  • Team player who works well with others
  • A commitment to providing excellent internal and external customer service