Job Title: Quality Control Senior Associate
Location: Holly Springs, NC 27540
Duration: 8 Months (Possibility of Extension)
Shift: 8:00 AM – 5:00 PM (Flexible start time between 7:00 AM – 9:00 AM)

Ideal Candidate Profile

• 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

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Role Overview

• 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)

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Key Responsibilities

• 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:

  • SOPs

  • Test methods

  • Safety assessments

  • Trend reports

  • Qualification/validation summary reports

  • Technical reports

• Support GMP QC lab startup activities

• Provide support during weekends and public holidays as needed

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Basic Qualifications

• High School Diploma/GED + 2 years of experience
  OR

• Associate’s Degree + 6 months of experience
  OR

• Bachelor’s Degree

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Top 3 Must-Have Skills

• 3+ years of GMP experience

• Deviation ownership with strong technical writing skills

• QC laboratory experience

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Nice to Have

• Experience with Veeva Quality Systems

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Day-to-Day Responsibilities

• Deviation ownership

• Change control ownership and management

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Red Flags

• No GMP experience

• No QC lab experience

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Interview Process

• Virtual interview

• 1–2 rounds

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 36.00/daily.