PSG Global Solutions
Documentation Specialist I
PSG Global Solutions, Westborough, Massachusetts, us, 01581
DescriptionWe're looking for a
Documentation Specialist I , working in
Biotechnology/Medical Devices
industry in
1 Research Drive, Westborough, Massachusetts, 01581, United States .
Job description:
Manage product complaints.Review and release production batch records.Review manage change controls.Providing Quality Review and approval of deviations related to Manufacturing Equipment, Facility and production.Participating on team to investigate deviations to determine appropriate root cause and CAPAs or may be responsible for CAPA resolution.Report metrics and create monthly and quarterly reports.Develop Sops as required.Performs in accordance with SOPs, safety and GMP guidelines to support release of finished product.Maintain and increase scientific, regulatory and compliance expertise and work with existing QA group to develop organizational and technical capabilities.Be current with various regulatory requirements and procedures.
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Documentation Specialist I , working in
Biotechnology/Medical Devices
industry in
1 Research Drive, Westborough, Massachusetts, 01581, United States .
Job description:
Manage product complaints.Review and release production batch records.Review manage change controls.Providing Quality Review and approval of deviations related to Manufacturing Equipment, Facility and production.Participating on team to investigate deviations to determine appropriate root cause and CAPAs or may be responsible for CAPA resolution.Report metrics and create monthly and quarterly reports.Develop Sops as required.Performs in accordance with SOPs, safety and GMP guidelines to support release of finished product.Maintain and increase scientific, regulatory and compliance expertise and work with existing QA group to develop organizational and technical capabilities.Be current with various regulatory requirements and procedures.
#J-18808-Ljbffr