QA Analyst Batch Release

Baltimore, MD 21230

Posted: 06/05/2019 Industry: Biotech/R&D/Science Job Number: 48997

Quality Assurance Analyst II, Batch Release

The QA Analyst II is responsible for performing duties related to the management of records relevant to the review and release of Batch Records for the cGMP operation in Baltimore.  Our QA Department provides expertise in problem solving and process improvements.  The QA Analyst will interact with all departments to provide guidance necessary to maintain and improve cGMP compliance at the company.

Batch Review and Release
  • Critically reviews GMP documents such as:
    • Executed batch records for a variety of different functional areas
    • Analytical Testing Data
    • Microbial and Environmental Monitoring Data
    • WFI testing data
    • Equipment Data
    • Logbooks
  • Perform SAP Transactions
  • Post release batch data entry
  • Review of documentation and authorization of shipments
  • Review and filling of Ancillary forms
  • Scanning and filling of released batch records
  • Initiate non-conformance investigations
  • Demonstrate strong organization skills related to priorities and work load. Ability to solve problems independently and within a team environment.

Quality Operations Support:
  • Author and execute tasks for document revisions, non-conformances, CAPAs, and change controls related to Document Control quality system performance.
  • Compile and report performance metrics for Batch Review and Release relevant activities

Continuous Improvement
  • Coordinate and lead department 6S activities.
  • Identify opportunities for improvement within scope of work.
  • Participate in operational excellence activities.

Regulatory Inspection
  • Provide logistical support and technical knowledge during regulatory and internal inspections of quality systems.

 

Education and Requirements:
  • BS degree in Chemistry/Biology or related discipline with 1-3 years Quality Control or Quality Assurance experience or a MS degree in Chemistry/Biology or related discipline with at least 1-year Quality Assurance experience, preferred.
  • 1 year in an FDA regulated industry is preferred.
  • Must have strong attention to detail.
  • Ability to manage multiple priorities and tasks in a dynamic environment.
  • Excellent written and verbal skills.
  • Ability to exercise judgment to determine appropriate corrective actions.
  • Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Ability to use computer programs.
  • Ability to work in a team environment.
  • Proficient knowledge of cGMP.

Ability to make sound decisions regarding compliance-related issues with moderate supervision.
Camden site in Baltimore For the other role focused on visual inspection, I have attached a job description. But…yes this is an QA support on the floor of our packaging operations with primary responsibility for QA visual inspection of products and QA review of packaging related batch records

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