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.
