QA Investigator

East Windsor, NJ
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Type: Direct-Hire

Category: Scientific & Clinical

Job ID: 218714

Date Posted: 04/09/2021


Title:  QA Investigator
Location:  East Windsor, NJ
Duration:  Direct Hire
Schedule:  M-F 8 AM-4:30 PM
Target Start Date: ASAP

Responsibilities:
As a key site Quality Employee the QA Investigator will be responsible for assuring that the investigations are conducted and written in compliance with all cGMP regulatory as well as facility requirements.
  • Leading, conducting, writing, reviewing and approving investigations for Deviations and Market Complaints.
  • Assisting SMEs in root cause analysis and trending.
  • Reviewing and approving CAPAs.
  • Responsible for the investigation/CAPA SOPs as well as performing training to employees.
  • Assist QA and Compliance as deemed necessary by the  Head of QA.
  • Leading, conducting, writing, reviewing and approving investigations for Deviations and Market Complaints.
  • Assisting SMEs in root cause analysis and trending.
  • Reviewing and approving CAPAs.
  • Responsible for the investigation/CAPA SOPs as well as performing training to employees.
  • Lead, facilitate, and conduct deviations, non-conformances investigations.
  • Identify  trends and root causes.
  • Identify and write investigation action plan as applicable.
  • Assist Subject Matter Experts in writing and conducting investigations.
  • Review and verify supporting documents and data for accuracy and completeness.
  • Write summary investigation reports with root causes as applicable.
  • Work with cross functional areas to determine the root cause/s and corrective and preventive actions.
  • Train personnel  as required on conducting investigations and root cause analyses and SOPs.
  • Review investigation reports for accuracy and completeness.
  • Maintain investigation database and submit monthly reports.
  • Ensure that investigations are completed in  a timely manner as required per site SOPs.
  • Initiate CAPAs, assign responsibilities, and follow-up for completion.
  • Schedule weekly meetings to assess status of the investigations.
  • Communicate/Escalate to management of issues for immediate attention.
  • Revise and update  deviation SOPs to comply w/ cGMPs and other regulatory requirements.
  • Review and approve  SOPs, protocols/reports, change controls and investigations.
  • 10% Train personnel on cGMPs and SOPs and Review and approve label proofs and C of As.
Requirements:
  • For BS, up to 5 years in a regulated pharmaceutical industry preferably in QA.
  • For MS or higher degree, up to 3 years in a regulated pharmaceutical industry preferably in QA.
  • Must be proficient with pharmaceutical drug manufacturing processes, cGMPs and other regulatory requirements.
  • Experience in conducting, writing non-conformance investigations, root cause analyses, and identifying corrective actions.
  • Experience in CAPA resolution and review of change Controls, SOPs, protocols/reports and quality indicator review.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
 

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