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QA Analyst II

Job Attributes

Job Id:

25904

Job Category:

Clinical & Life Sciences

Job Location:

Baltimore, MD  21201

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

Piper Clinical Solutions is seeking a motivated Quality Assurance Analyst II to support Batch Review and Release activities for a global specialty biopharmaceutical company in Baltimore, MD.

 

Responsibilities for the QA Analyst II:

·       Perform duties related to the management of records relevant to the review and release of Batch Records for the cGMP operation

·       Provides expertise in process improvements and problem solving

·       Perform SAP Transactions

·       Post release batch data entry

·       Review of documentation and authorization of shipments

·       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

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

 

 

Requirements for the QA Analyst II:

·       Master’s Degree in Chemistry or Biology

·       Bachelor’s Degree in Science Related Field

·       1 + years of experience in Quality Control or Quality Assurance

·       1 + years in an FDA regulated industry and knowledge of cGMP

 

Compensation for the QA Analyst II:

·       $60,000+ commensurate based on meeting of requirements

·       Benefits: PTO, Paid Holidays, Health, Dental, Vision Insurance, 401(k)

 

 

Please send all qualified resumes to: scastle@pipercompanies.com

                                          

Keywords: QA Analyst, Biology, biopharmaceutical, BioSolutions, cGMP, Good Manufacturing Practice, quality control, quality assurance, FDA regulations, document control, quality system performance, QA, QC, batch review, Batch release, process improvement, investigations, CAPA, deviations, OOS, Compliance, benefits, 401k, chemistry, analytic testing data, logbooks, WFI testing data, Microbial monitoring data, Environmental Monitoring Data

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New Search

Job Id:

25904

Job Category:

Clinical & Life Sciences

Job Location:

Baltimore, MD  21201

Security Clearance:

No Clearance

Business Unit:

Piper Companies