Analyst, Quality Control

YolTech Therapeutics

$88K — $105K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in chemistry, biochemistry, pharmaceutical science, or related field.
  • 5-7 years of QC analytical experience in a GMP-regulated laboratory.
  • Strong understanding of cGMP, GDP, and data integrity regulations.
  • Hands-on experience with chromatographic and analytical instrumentation.
  • Excellent documentation and technical writing skills.

Responsibilities

  • Perform routine and complex analytical testing according to protocols and standards.
  • Review data and results for accuracy and compliance.
  • Lead method validation and troubleshooting initiatives.
  • Execute various testing assignments as needed.
  • Support laboratory investigations and compliance assessments.
  • Maintain and calibrate analytical instruments and systems.
  • Prepare and update methods, SOPs, and training materials.

Benefits

  • Comprehensive medical, dental, and vision insurance with significant employer contributions.
  • Basic life and optional supplemental life insurance.
  • Employer-paid disability insurance.
  • 401k plan with a generous matching contribution.
  • 10 days of paid time off (PTO) per year.
  • Company-wide paid holidays including multiple extended breaks.
  • Transportation reimbursement for carpooling and clean air vehicles.
  • Employee recognition programs and social events.
  • Team building activities sponsored quarterly.
Full Job Description
We are seeking an experienced Quality Control Analyst to perform and review analytical testing supporting raw-material, in-process, release, stability, validation, and investigation activities. Core duties and responsibilities include the following: Job Duties: • Perform and document routine and complex analytical testing in accordance with approved methods, specifications, SOPs, protocols, and schedules. • Review raw data, calculations, chromatograms, audit trails, worksheets, and results for accuracy, completeness, and compliance. • Support or lead method transfer, verification, validation, troubleshooting, and lifecycle improvements for assigned methods. • Execute raw-material, in-process, release, stability, cleaning, or investigation testing as assigned. • Lead or support laboratory investigations, OOS/OOT assessments, deviations, CAPAs, and change controls. • Operate, maintain, calibrate, and troubleshoot analytical instruments and laboratory systems; coordinate service when needed. • Prepare and revise methods, SOPs, protocols, reports, specifications, forms, and training materials. • Train and mentor analysts and provide technical guidance while preserving independent review requirements. • Plan work against manufacturing and project priorities and communicate constraints or risks early. • Support inspections, customer audits, data requests, and continuous-improvement initiatives. Requirements • Bachelor's degree in chemistry, biochemistry, pharmaceutical science, or a related field. • 5-7 years of QC analytical experience in pharmaceutical, biotechnology, API, or another GMP-regulated laboratory. • Strong knowledge of cGMP, GDP, data integrity, OOS/OOT, deviations, CAPA, and controlled-document practices. • Hands-on experience with relevant chromatographic and analytical instrumentation, data systems, and method troubleshooting. • Strong documentation, technical writing, prioritization, and cross-functional communication skills. Benefits • Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 85% for Employee and 50% for Employee's family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed) • Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental). • Disability insurance 50% standard employer paid. • 401k 10% 1:1 match • PTO policy. 10 days PTO • Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25 • Carpool, clean air vehicle, and cell phone reimbursement • Employee rewards and recognition program • Company organized social events • Quarterly sponsored team building activities

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