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Quality Assurance Specialist

Ascent

Job Description

Quality Assurance Specialist
Novato, CA
 
This position is responsible for performing Quality Assurance (QA) review of Contract Manufacturing Organization (CMO) manufacturing batch records and associated documentation. This includes receipt, QA review and archival of executed manufacturing batch records and associated documentation such as QC test forms, and updating QA databases. QA review of manufacturing batch records includes verifying conformance to cGMPs, SOPs and batch record process limits.
 
RESPONSIBILITIES
  • The individual is expected to communicate well with CMO/Packaging Ops, Quality Assurance, Quality Control, Regulatory Affairs, and Supply Chain and CMOs.
  • Perform QA review of Manufacturing executed batch records and associated documentation for compliance with cGMPs, SOPs, and other polices and procedures.
  • Ensure adherence to company policies/procedures, regulatory licenses, applicable Quality and Technical agreements, industry standards, and GMP regulations.
  • Receive, control, scan and archive CMO executed batch records.
  • Prepare lot history folders for Drug Product (DP) lots.
  • Update QA CMO datases/Oracle EBS
  • Obtain data for complaint investigation, etc.
  • Other QA CMO duties as assigned.
 
EXPERIENCE
  • 1-5 years of directly related experience in a GMP Quality or Manufacturing environment.
  • Working knowledge of process and desktop computers. Proven comprehension of technical information and regulatory expectations.
  • The ideal candidate will have strong organization and communication skills.

Job Requirements

 
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Job Snapshot

Location US-CA-Novato
Employment Type Contractor
Pay Type Hour
Pay Rate N/A
Store Type Clinical & Scientific

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Terms & Conditions
Snapshot
Ascent
Company:
US-CA-Novato
Location:
Contractor
Employment Type:
Hour
Pay Type:
N/A
Pay Rate:
Clinical & Scientific
Store Type:

Job Description

Quality Assurance Specialist
Novato, CA
 
This position is responsible for performing Quality Assurance (QA) review of Contract Manufacturing Organization (CMO) manufacturing batch records and associated documentation. This includes receipt, QA review and archival of executed manufacturing batch records and associated documentation such as QC test forms, and updating QA databases. QA review of manufacturing batch records includes verifying conformance to cGMPs, SOPs and batch record process limits.
 
RESPONSIBILITIES
  • The individual is expected to communicate well with CMO/Packaging Ops, Quality Assurance, Quality Control, Regulatory Affairs, and Supply Chain and CMOs.
  • Perform QA review of Manufacturing executed batch records and associated documentation for compliance with cGMPs, SOPs, and other polices and procedures.
  • Ensure adherence to company policies/procedures, regulatory licenses, applicable Quality and Technical agreements, industry standards, and GMP regulations.
  • Receive, control, scan and archive CMO executed batch records.
  • Prepare lot history folders for Drug Product (DP) lots.
  • Update QA CMO datases/Oracle EBS
  • Obtain data for complaint investigation, etc.
  • Other QA CMO duties as assigned.
 
EXPERIENCE
  • 1-5 years of directly related experience in a GMP Quality or Manufacturing environment.
  • Working knowledge of process and desktop computers. Proven comprehension of technical information and regulatory expectations.
  • The ideal candidate will have strong organization and communication skills.

Job Requirements

 
Quality Assurance Specialist Apply now