QA Associate/Specialist

3 weeks ago

Florham Park, United States Clinical Resource Network (CRN) Full time

Our client is looking to fill the role of the The Quality Assurance (QA) Specialist. This person will reviews Batch Production Records and laboratory Certificates of Analysis to confirm accuracy and product release acceptability for product release. Work with cross functionally to ensure product quality, change control review and handle quality investigations. This role will be on site in the Florham, Park location. They are seeking multiple levels such as 1-3 years and 3-7 years.


Responsibilities:


  • Conducts QA review of product-related records for completeness and accuracy.
  • Perform batch disposition and ensure quality decision of all documentation related to batch records.
  • Conduct issuance of Batch records and labels.
  • Support inspection and release of incoming materials.
  • Product packaging and labeling verification and reconciliation.
  • Conducts QA review and approval of various calibration, validation and environmental monitoring documents for accuracy and trends.
  • Coordinates/lead investigation activities associated with CAPAs and event resolution.
  • Ensure adherence of appropriate Health Authority regulations.
  • Author and review various pertinent documents such as Standard Operating Procedures (SOPs), Quality Risk Assessments (QRAs) and Batch Production Documents (BPDs).
  • Provide support for any required external audits and internal inspections.
  • Support regulatory filings.


Requirements:


  • Good Laboratory Practices (GLP) knowledge.
  • Ability to assist with OOS (Out of Specification), OOT and CAPAs
  • Familiarity with cGMP environment (i.e., ISO 5, ISO 7, and ISO 8).
  • Perform trend analysis via MS Excel and other software.
  • Bachelor’s degree in a scientific discipline required.
  • 2+ years of quality assurance experience
  • Strong working knowledge and ability in using Microsoft Office.
  • Knowledge/experience with electronic quality systems and enterprise resource planning systems is highly preferred (e.g., Veeva, TrackWise, Salesforce and Great Plains).


If you meet the required qualifications and are interested in this role, please apply today.

Clinical Resource Network Distinction


CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.


About CRN


Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit and connect with us on Facebook and LinkedIn.


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