Job Description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://www. qrcgroup.com to learn more about our services and solutions!

Specialist QA with experience in regulated industry. Expertise in NPI, Change Control, FATs, Validation and PPQs.

Duties:

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Request Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Lead site audits.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Review Risk Assessments.
• Support Automation activities.
• Support facilities and environmental programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Approve NC investigations and CAPA records.
• Approve change controls.
• Provide lot disposition and authorize lots for shipment.

Qualifications

• Doctorate or Master's Degree and 2 years of experience of Quality Manufacturing support
  
  Bachelor's Degree and 4 years of experience of Quality Manufacturing support or
  
  Associate Degree and 8 years of experience of Quality or Manufacturing support (Educational background in Life Sciences and/or Engineering).
• Expertise in NPI, Change Control, FATs, Validation and PPQs
• Bilingual (English and Spanish)

Additional Information

All your information will be kept confidential according to EEO guidelines.