Sr. Quality Assurance Associate

At-a-Glance:

Are you ready to build your career by joining a global pharmaceutical company? If so, our client is hiring a Sr. Quality Assurance Associate!

Position Type:

• Contract
• Hybrid
  
  
  

Required:

Education:

• Associate degree (required); BS/BA in pertinent life sciences or closely related field (preferred).
  
  
  

Technical:

• 3 years of pharmaceutical/biotech working experience in a cGMP Quality Control, analytical development, analytical transfer, or validation department in an FDA-regulated industry.
• Familiarity with data trending and monitoring controls.
• Hands-on experience within a bioanalytical lab. Familiarity with equipment and test methods which may include HPLC, CE, PCR, ELISA, gel-based assays and other compendial assays used to test biopharmaceuticals.
• Familiarity with Method Validation, Analytical Transfers, or laboratory investigation experience.
• Thorough understanding of principles, practices, and standards for biopharmaceutical testing.
• Well versed in ICH and regulatory requirements for quality as it relates to QC operations, Laboratory compliance, data integrity, and quality events.
• Experience performing statistical analysis of data sets using software such as JMP or Minitab is a plus.
• Proficient in Microsoft Office tools, Minitab, Veeva Quality systems.
  
  
  

Must Possess:

• Strong organization and communication skills and technical writing skills.
• Must be self-directed, goal-oriented, and quality conscious.
• High attention to detail with the ability to rapidly see the big picture and assess the impact of data and/or decisions.
• Values consistent with Client Values (integrity, respect, professionalism, quality and teamwork); together with an intrinsic understanding of hhc mission and the need to always think first of the patient.
  
  
  

Responsibilities:

Essential Functions:

• Data review, data management of routine testing executed by contract laboratories for commercial Biologics including:
• Data review, data management to support use of electronic systems such as Veeva Quality eDocs, Minitab.
• Perform and support data trending, interpretation and statistical analysis of commercial release and stability studies, for assay controls or reference standards and invalid assay trending.
• Monitoring release and stability data to ensure data integrity, regulatory compliance, product quality, and on-time completion.
• Acting as the technical reviewer of data sets, quality records and lab investigations generated by contract test labs.
• Authoring CoAs, technical reports, internal quality records in accordance with regulatory requirements.
• Serving as the SME for product specific test methods for internal and external quality control.
• Collaborating frequently with internal and external cross-functional groups to provide status updates, workflows, and timelines for routine testing activities. These groups include CMOs/contract test labs, manufacturing operations, quality, regulatory and program management.
• Monitoring product specific reference standard programs in collaboration with the network Analytical/Quality experts to sustain routine testing activities. This includes driving efforts for reference standard qualification, annual re-qualification, and distribution to contract test labs.
• Supporting analytical method validation and method transfer activities.
  
  
  

Get in Touch:

If you think you'd be a good match, submit your resume and reach out to Rishaw at 862-895-5483 to learn more.

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