Quality Assurance Specialist at Spectrum Staffing Services/HRStaffers Inc. in Edison, New Jersey

Job Description:

• Conduct batch record reviews and manage the release process
• Review completed or executed batch records and follow up on errors
• Attach supportive materials to the completed records
• Create and maintain error logs
• Review and validate completed raw material inventory cards
• Draft quality assurance procedures (such as SOPs) and provide support in driving the improvement programs in the Quality Assurance Team
• Review and approve of SOP's; provided consultation in development of new SOP's to ensure product development conforms with GXPs
• Review investigations and provide support in implementation of CAPAs as needed
• Review change control and ensure proper assessment is performed and action plan is documented to implement the change control
• Handle certificate of analysis and certificates of compliance
• Other duties as assigned

• 4 years experience working within QA
• Prior experience working with a CMO preferred
• Bachelors Degree