Quality Control Analyst

Quality Control Analyst

Birmingham, AL

Tunnell Consulting is an employee-owned, life sciences management consulting firm. Known for solving complex problems in the life sciences, we support the mission and objectives of a variety organizations including biotech, pharma, the U.S. Government, foundations, public/private partnerships, investors, and emerging companies. The variety of clients and issues that we support give our team and our organization an ever-increasing breadth of experience to add to our deep industry and functional expertise. Headquartered in the Philadelphia area, we also have a presence in Washington DC, and Boston.

Job Title: QC Analyst – HPLC Specialist
Employment Type: 40 hour/week contract role

Job Summary:

Tunnell is seeking a detail-oriented and experienced Quality Control (QC) Analyst with hands-on expertise in performing assays using High-Performance Liquid Chromatography (HPLC).  In this role, the QC Analyst will be responsible for conducting analytical testing of raw materials, in-process samples, and finished products in compliance with cGMP standards and regulatory requirements.  This is estimated to be a 3-month project with potential for temp to perm conversion.   Client is based in the greater Birmingham, AL area.  Local candidates only.

Key Responsibilities:

• Perform qualitative and quantitative testing using HPLC, following established SOPs and analytical methods.
• Interpret chromatograms, troubleshoot HPLC instrumentation issues, and ensure accurate, reliable data reporting.
• Prepare samples and standards in accordance with method requirements.
• Document all work in accordance with Good Documentation Practices (GDP).
• Support method development, validation, and transfer activities as needed.
• Maintain laboratory equipment, ensuring regular calibration and qualification.
• Contribute to laboratory investigations and contribute to CAPA (Corrective and Preventive Actions) when deviations occur.
• Collaborate with cross-functional teams including R&D, QA, and production.
• Follow all safety and compliance protocols within the laboratory environment.

Qualifications:

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• 2-3 years of experience in a QC laboratory environment, with proven proficiency using HPLC (e.g., Waters, Agilent systems).
• Familiarity with cGMP and regulatory guidelines (FDA, ICH).
• Experience with additional analytical techniques such as UV-Vis, GC, FTIR, or Dissolution is a plus.
• Strong technical writing and documentation skills.
• Ability to work independently and as part of a team in a fast-paced environment.

Preferred Skills:

• Experience with chromatography software (e.g., Empower, ChemStation).
• Knowledge of pharmaceutical or biotech product testing.