QC Sr. Specialist

Echo IT Solutions, Inc.

$80K — $110K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Biochemistry, Biology, Microbiology, or a related field
  • 8 years of GMP experience or 7 years at GTx
  • Proficient in testing methods such as ELISA, PCR, HPLC, CE, and AUC
  • Strong communication skills coupled with excellent technical writing
  • Demonstrated teamwork, problem-solving, and independent judgment

Responsibilities

  • Coordinate QC activities and manage method transfers
  • Support evaluations, detailed documentation, and internal audits
  • Perform trend analysis and review data to ensure compliance with specifications
  • Lead investigations including deviations, OOS/OOT/OOE events
  • Author and update SOPs, reports, and protocols
  • Oversee analytical projects and resolve instrument-related issues
  • Support training initiatives and drive continuous improvement efforts
Full Job Description
Job Title: QC Sr. Specialist
Job Type: Long Term Contract
Location: Durham, NC (Onsite Role)

Job Description:
Support compliance and conformance to quality standards in manufacturing and production.

Key Responsibilities:
  • Coordinate QC activities and method transfers
  • Support evaluations, documentation, and internal audits
  • Perform trend analysis and review data for specification compliance
  • Lead investigations (Deviation, OOS/OOT/OOE)
  • Author and revise SOPs, reports, and protocols
  • Oversee analytical projects and instrument problem-solving
  • Support training and continuous improvement

Requirements:
  • Bachelors in Biochemistry, Biology, Microbiology, or related
  • 8 years in GMP or 7 years at GTx
  • Proficient in testing methods: ELISA, PCR, HPLC, CE, AUC, etc.
  • Excellent communication and technical writing
Strong teamwork, problem-solving, and independent judgment

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