QA Investigator


Job ID 18-00326

Industry Pharma

Job Type Permanent

Location Dayton, NJ

Description

SUMMARY:
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. This individual will be responsible for;

• Leading, conducting, writing, reviewing and approving investigations
• 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

 

REPORTING RELATIONSHIPS

No Direct Reports

This role reports directly to the Director, Quality Assurance for Client Pharma, LLC

 

DUTIES & ESSENTIAL JOB FUNCTIONS

The responsibilities in general include but not limited to the following and may change at the discretion of Head of QA
1. Manufacturing/Deviation/Non Conformance Investigations:
1.1 Lead, facilitate, and conduct deviations, non-conformances investigations
1.2 Identify trends and root causes
1.3 Identify and write investigation action plan as applicable
1.4 Assist Subject Matter Experts in writing and conducting investigations
1.5 Review and verify supporting documents and data for accuracy and completeness
1.6 Write summary investigation reports with root causes as applicable
1.7 Work with cross functional areas to determine the root cause/s and corrective and preventive actions
1.8 Train personnel as required on conducting investigations and root cause analyses and SOPs
1.9 Review investigation reports for accuracy and completeness
1.10 Maintain investigation database and submit monthly reports
1.11 Ensure that investigations are completed in a timely manner as required per site SOPs
1.12 Initiate CAPAs, assign responsibilities, and follow-up for completion
1.13 Schedule weekly meetings to assess status of the investigations
1.14 Communicate/Escalate to management of issues for immediate attention
1.15 Revise and update SOPs to comply w/ cGMPs and other regulatory requirements
1.16 Review and approve SOPs, protocols/reports, change controls and investigations
2. Other
2.1 Train personnel on cGMPs and SOPs
2.2 Assist QA and Compliance as deemed necessary by the Head of QA
And any other duties that may be assigned to assist the department and overall company.



Qualifications

QUALIFICATIONS

  • Train personnel on cGMPs and SOPs
  • Review and approve SOPs, validation protocols/reports, change controls, label proofs, and investigations
  • Assist QA as deemed necessary by the Site QA Director
  • Assist QA Compliance as and when necessary

 

Educational Qualification:

  • BS or higher degree in scientific discipline
  • Excellent technical writing skills, communication skills, organization skills
  • Must be able to speak, read, and write in English

 

Work Experience:

  • For BS, at least 10-years in a regulated pharmaceutical industry with 7 years as QA/Manufacturing Investigator
  • For MS or higher degree, at least 7-years in a regulated pharmaceutical industry with 5 years as QA/Manufacturing Investigator
  • 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
  • Proficient in computer software; excel, access, power-point, Track-Wise etc.
  • Must be able to work independently in a team environment

 

PREFERRED

  • For BS, at least 10-years in a regulated pharmaceutical industry with 7 years as QA/Manufacturing Investigator
  • For MS or higher degree, at least 7-years in a regulated pharmaceutical industry with 5 years as QA/Manufacturing Investigator
  • 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