Demo

Sr. QA Specialist - Quality Department

On-Board Companies
Franklin, NJ Full Time
POSTED ON 1/16/2025
AVAILABLE BEFORE 4/9/2025

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

    Tag : INDOJ

    Salary : $25 - $35

    If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution. Compensation Planning
    Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right. Surveys & Data Sets

    What is the career path for a Sr. QA Specialist - Quality Department?

    Sign up to receive alerts about other jobs on the Sr. QA Specialist - Quality Department career path by checking the boxes next to the positions that interest you.
    Income Estimation: 
    $99,704 - $121,947
    Income Estimation: 
    $124,827 - $154,865
    Income Estimation: 
    $91,761 - $124,963
    Income Estimation: 
    $70,600 - $83,423
    Income Estimation: 
    $109,109 - $156,982
    Income Estimation: 
    $83,806 - $99,902
    Income Estimation: 
    $101,442 - $121,314
    Income Estimation: 
    $101,442 - $121,314
    Income Estimation: 
    $122,860 - $148,594
    Income Estimation: 
    $68,970 - $84,869
    Income Estimation: 
    $83,806 - $99,902
    View Core, Job Family, and Industry Job Skills and Competency Data for more than 15,000 Job Titles Skills Library

    Job openings at On-Board Companies

    On-Board Companies
    Hired Organization Address Indianapolis, IN Full Time
    On-Board Scientific is hiring a Laboratory Technician (Chemistry) in Indianapolis, IN For immediate consideration please...
    On-Board Companies
    Hired Organization Address Belvidere, NJ Full Time
    On-Board Scientific is hiring a QC Lab Technician based out of Belvidere, NJ! Wednesday-Sunday - 8a-4:30p) For immediate...
    On-Board Companies
    Hired Organization Address Dayton, OH Full Time
    On-Board PMO is hiring Full-time Production Assistants in Dayton, OH! About Us: On-Board PMO, Incorporated is an on-site...
    On-Board Companies
    Hired Organization Address Dallas, TX Full Time
    On-Board Services is hiring a Supply Chain Planner in Dallas , TX ! For immediate consideration please send your resume ...

    Not the job you're looking for? Here are some other Sr. QA Specialist - Quality Department jobs in the Franklin, NJ area that may be a better fit.

    Sr, Quality Systems Specialist

    1000 Becton, Dickinson and Company, Franklin, NJ

    AI Assistant is available now!

    Feel free to start your new journey!