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Sr. QA Specialist

2 months ago

Somerset, United States On-Board Companies Full time
On-Board Scientific is hiring a QA Specialist, Change Control/CAPA based out of the New Brunswick/Somerset, NJ area
For immediate consideration please send your resume to resumes@onboardusa.com
Subject Line: Position Title and State you are located

About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full-time positions to our employees. We offer benefits as well as 401k.

Position Details:
Position Type: 1 year contract with additional opportunity contingent upon performance and continued business need
Job Location: New Brunswick/Somerset, NJ
Shift: 1st shift Benefits:
Compensation: $25-$35 per hour

Individual selected with be responsible the review and oversight to all the Change Controls and CAPAs proposed for manufacturing, packaging and testing processes to ensure that the Changes Controls and CAPAs are performed in a timely and controlled manner in compliance with approved procedures to produce the desired outcomes.

Responsibilities:
  • Support policies and procedures for Change Control and CAPA systems consistent with FDA regulations and corporate requirements
  • Serves as Change Control coordinator to ensure that all change proposals have comprehensive rationale, impact assessment, and implementation plans and follow up actions documented. Ensures that all approved actions are implemented as per commitment.
  • Convene weekly change control committee meetings to escalate level II changes for committee's review. Conduct / Review risk assessments where necessary.
  • Collaborate with SMEs from various functional departments to ensure that changes are reviewed and approved, consistent with requirements of site / corporate SOPs.
  • Ensure that Corrective and Preventive actions identified through investigation and audit processes are properly documented and implemented.
  • Follow up with Change Control / CAPA owners to ensure timely implementation.
  • Develop and monitor site metrics and reports for Change Controls and CAPAs. Report progress to site leadership periodically.

Qualifications:
  • Minimum Bachelor Degree in a scientific or technical field; graduate degree desired
  • 3+ years' of extensive experience in the pharmaceutical industry in Quality Assurance. Cross functional experience in Engineering, Technical Operations, Regulatory Affairs, Product development or Laboratory is a plus
  • Working knowledge of FDA and applicable non-US regulations, guidance and industry standards pertaining to pharmaceutical drug manufacturing. Participation in FDA / customer audits is desirable
  • Experience with Process / Method validation, Equipment / Facility Qualification and Regulatory requirements for product submissions is a big plus
  • Thorough understanding of Cross-functional Quality Systems such as Deviations, Complaints, OOS is mandatory.
  • Experience in using electronic Quality Management System, ERP system, MS Office applications. Experience with Trackwise is preferable.
  • Excellent analytical, coordination and influential skills; Must be able to persuade cross functional teams to achieve results

Apply Today
www.onboardusa.com

On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.

The On-Board Family of Companies conducts operations through its Corporate Headquarters located in
East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board's Mission is to provide "Flexible Service by applying the talents of our people, work processes and technology to meet our clients' expectations in a Safe, Responsible and Dependable manner."

On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.

JD# 24-02090
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