QA Compliance Specialist in West Caldwell, NJ at Volt

Date Posted: 9/20/2021

Job Snapshot

Job Description

QA Compliance Specialist

West Caldwell, NJ


Join the Quality team at this growing pharmaceutical company!


  • Assure compliance with the company procedures and CGMP regulations for products that are introduced to the site and as they progress through product lifecycle.
  • Function as QA representative on internal and external product cross functional teams and multi-disciplinary meetings.
  • Provide QA oversight for assigned investigations and ensure that investigations are processed through closure in accordance with company procedures and an appropriate impact assessment, root cause analysis and CAPA action(s) have been identified.
  • Actively participate in effective deployment of the CAPA System (proposing, initiation, implementation, closure).
  • Review and approve Quality Management System Documentation such as SOPs, Master Batch Records and Specifications
  • Review and approve Technology Transfer, Validation and Equipment Qualification Protocols and Reports to ensure compliance to procedures and processes.
  • Provide QA oversight for on-floor surveillance of development GMP batch processing as needed and for other applicable quality related events.
  • Work closely with internal departments, including Operations, Technical Transfer, Validation, and QC to assure compliance with internal quality systems and regulations issued by the FDA, and other applicable regulatory bodies
  • Perform regular facility monitoring; efficiently follow up on observations and comments
  • Perform Internal Audits (if assigned) including preparation, execution of the audit plan and create Internal Audit reports and agreement on appropriate CAPAs.
  • Prepare summaries of investigations, CAPAs and CAPA effectiveness checks for inclusion in the Annual Product Review process.
  • Create new SOPs as directed
  • Perform ad hoc QA projects as assigned by management
  • Ability to gown up and enter the manufacturing plant.


  • Bachelor’s Degree
  • 5-6 years’ in Quality and/or Pharmaceutical field
  • Excellent reading, writing and verbal skills
  • Proficient in word, excel and power point including strong report writing and computer program familiarity.  Micro and environmental monitoring experience and knowledge strongly preferred.
  • Above average mathematic skills
  • Excellent team player
  • Knowledge in CRR parts 210, 211 and 820 regulations, ICH Q8/Q9/Q10 guidelines for process development and current regulatory GMP initiatives

1st shift hours/day shift.  Mon-Fri

 VOLT is an equal opportunity employer.