Analytical Chemistry Investigation Specialist

Location: Houston, Texas, United States. Laboratory and office-based role with cross-functional departmental interaction; occasional extended hours may be required for critical investigations or deadlines.

Company

hirify.global is an FDA-registered cGMP scientific solutions provider offering pharmaceutical, biotechnology, compounding, healthcare, and clinical research testing and calibration services.

What you will do

• Lead, conduct, and document investigations into laboratory deviations, non-conformances, OOS/OOT results, and other quality events.
• Perform root cause analysis using analytical data, laboratory records, and supporting documentation.
• Analyze analytical chemistry data to identify trends, anomalies, and potential risks.
• Develop, recommend, and track corrective and preventive actions.
• Prepare compliant investigation reports and ensure investigations meet established timelines and regulatory standards.
• Collaborate with Quality Assurance, Production, R&D, and Regulatory Affairs, and support internal and external audits.

Requirements

• Bachelor’s degree in Chemistry, Analytical Chemistry, or a related scientific discipline; a master’s degree is preferred.
• 3–5+ years of experience in a regulated laboratory environment, such as pharmaceutical or biotechnology operations.
• Strong knowledge of analytical techniques including HPLC, GC, UV-Vis, FTIR, or similar instrumentation.
• Experience with OOS and deviation investigations, CAPA processes, GMP, FDA, and ICH requirements.
• Strong problem-solving, critical-thinking, analytical, written communication, organizational, and prioritization skills.
• Experience with method validation, method transfer, stability testing, regulatory inspections or audits, and statistical trending methodologies.

Nice to have

• Master’s degree in Chemistry or a related field.
• HPLC certification.
• Prior involvement in regulatory inspections or audits.

Culture & Benefits

• Work in a state-of-the-art FDA-registered cGMP testing and calibration laboratory.
• Contribute to patient-safety-focused scientific and compliance solutions.
• Collaborate with pharmaceutical, medical device, compounding pharmacy, hospital, and clinical research clients.
• Support continuous improvement and science-based approaches to healthcare challenges.