Quality Control Senior Associate

Minimum 3 years of industry experience in a GMP-regulated biotech or pharmaceutical environment

Strong knowledge of quality systems and QC lab operations

Experience in writing, owning, and closing quality records (deviations, CAPAs, change controls)

Excellent technical writing, grammar, and investigation leadership skills

Detail-oriented, proactive, and able to manage shifting priorities in a fast-paced environment

Comfortable working cross-functionally and leading meetings/investigations independently

Experience with Veeva Quality Systems is highly desirable

Part of the QC Deviation & Change Control team supporting startup and operations of the ANC facility

Collaborate with Quality and QA teams to manage quality systems in DQMS (Veeva)

Write, own, and manage deviations and change controls in Veeva

Lead investigation teams and track/report system metrics

Review validation documents for equipment and computerized systems

Author, revise, and review:

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  SOPs

  
  
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  Test methods

  
  
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  Safety assessments

  
  
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  Trend reports

  
  
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  Qualification/validation summary reports

  
  
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  Technical reports

  
  

Support GMP QC lab startup activities

Provide support during weekends and public holidays as needed

High School Diploma/GED + 2 years of experience

OR

Associate's Degree + 6 months of experience

OR

Bachelor's Degree

3+ years of GMP experience

Deviation ownership with strong technical writing skills

QC laboratory experience

Experience with Veeva Quality Systems

Deviation ownership

Change control ownership and management

No GMP experience

No QC lab experience

Virtual interview

1-2 rounds