Senior QC Chemist – cGMP, HPLC & Stability Testing

Acrotech Biopharma Inc

Durham (NC)

On-site

USD 80,000 - 89,000

Full time

14 days+

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Benefits offered by this job

Medical insurance
Dental insurance
Vision plan
Life Insurance
401(k) Plan
Paid Time Off

Job summary

Aurolife is seeking a QC Chemist C to perform a range of analytical tests to assess strength, identity and purity of samples within the stability team. The role emphasizes bench work (80–100%) and involves review of analytical documents, investigations, and GLP status maintenance.

The ideal candidate has 5+ years in pharmaceutical analytics, experience with cGMP, and familiarity with EMPOWER CDS and LIMS. Flexible hours and teamwork are needed to meet product deliverables in a fast-paced setting.

Qualifications

  • BS or MS in Chemistry or Pharmaceutical Sciences, or related field.
  • Minimum 5+ years of experience in Pharmaceuticals and Analytical testing.
  • Preference shall be given for experience in Inhalation testing on a variety of Inhalation products.

Responsibilities

  • Perform in-process, finished product and stability testing using wet chemicals and instrumental techniques (HPLC, UPLC, GC, UV‑Vis, IR, Particle Size Analyzer, KF Auto titrator, Bulk Density) per Finished Product methods.
  • Independently plan and execute testing to meet established time-lines with minimal supervision.
  • Assist with preparation or review of Test Procedures, SOPs, Protocols, and CoAs as assigned.
  • Record data and results following documentation procedures; ensure accurate, clear documentation.
  • Calibrate and maintain laboratory instruments with limited supervision.
  • Assist investigations for OOS/OOT/Deviation under supervisor guidance.
  • Draft deviation reports as assigned and ensure compliance with regulatory requirements.

Skills

EMPOWER CDS
LIMS
cGMP experience
GxP documentation
USP/ICH/FDA guidelines
team player
flexible hours
quick learner

Education

BS in Chemistry or Pharmaceutical Sciences
MS in Chemistry or Pharmaceutical Sciences

Job description

Aurolife is seeking a QC Chemist C to perform a range of analytical tests to assess strength, identity and purity of samples within the stability team. The role emphasizes bench work (80–100%) and involves review of analytical documents, investigations, and GLP status maintenance.

The ideal candidate has 5+ years in pharmaceutical analytics, experience with cGMP, and familiarity with EMPOWER CDS and LIMS. Flexible hours and teamwork are needed to meet product deliverables in a fast-paced setting.

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