Analytical Chemistry Investigation Specialist

BioSpace; Houston (TX); On-site; USD 95,000 - 125,000; Full time

Job summary

BioSpace is seeking an Investigation Specialist with expertise in Analytical Chemistry to lead investigations into laboratory deviations and OOS results. You will perform root cause analysis, develop CAPAs, and prepare compliant reports while collaborating with QA, Production, R&D, and Regulatory Affairs.

The role requires 3–5+ years in a regulated lab, strong analytical skills, and familiarity with GMP and regulatory requirements. Occasional extended hours may be needed to meet deadlines.

Qualifications

• Bachelor's in Chemistry or Analytical Chemistry; Master’s preferred.
• 3–5+ years in a regulated lab environment (pharma/biotech).
• Experience with OOS/deviation investigations and CAPA processes.
• Familiarity with GMP and regulatory requirements (FDA, ICH).
• Knowledge of analytical techniques (HPLC, GC, UV-Vis, FTIR).
• Strong problem-solving, written and verbal communication, and documentation skills.

Responsibilities

• Lead and document investigations into deviations, OOS/OOT results, and quality events.
• Perform root cause analysis using analytical data and records.
• Develop and track CAPAs for timely resolution.
• Prepare compliant investigation reports per procedures and regs.
• Collaborate with QA, Production, R&D, and Regulatory Affairs to implement solutions.
• Ensure investigations meet timelines and audit requirements.
• Support audits with documentation and SME input.
• Identify recurring issues and contribute to continuous improvement.
• Stay current with regulatory guidelines and best practices in analytical chemistry.

Skills

Analytical thinking

Problem solving

Strong communication

Detail oriented

Multitasking

GMP knowledge

Regulatory awareness

Cross-functional collaboration

Documentation skills

Time management

Education

Bachelor's in Chemistry/Analytical Chemistry

Master's degree preferred

Tools

HPLC

GC

UV-Vis

FTIR

Job description

Job Details

Description

What We're Looking For

We are seeking a highly skilled and detail-oriented Investigation Specialist with expertise in Analytical Chemistry to join our team. This role is responsible for leading and supporting investigations related to laboratory deviations, out-of-specification (OOS) results, and other quality-related issues. The ideal candidate will possess strong analytical capabilities, a thorough understanding of laboratory operations, and the ability to interpret complex scientific data to drive effective root cause analysis and corrective actions.

What You Will Do

• Lead, conduct, and document investigations into laboratory deviations, non-conformances, OOS/OOT (Out-of-Trend) results, and quality events.
• Perform detailed root cause analysis using analytical data, laboratory records, and supporting documentation.
• Analyze and interpret complex analytical chemistry data to identify trends, anomalies, and potential risks.
• Develop, recommend, and track corrective and preventive actions (CAPAs) to ensure timely and effective resolution.
• Prepare clear, concise, and compliant investigation reports in accordance with internal procedures and regulatory requirements.
• Collaborate cross-functionally with Quality Assurance, Production, R&D, and Regulatory Affairs to support investigations and implement solutions.
• Ensure investigations are completed within established timelines and meet compliance standards.
• Support internal and external audits by providing documentation and subject matter expertise as needed.
• Identify recurring issues or trends and contribute to continuous improvement initiatives.
• Maintain a strong understanding of current regulatory guidelines and industry best practices related to analytical chemistry and quality systems.

Who You Are

• Bachelor’s degree in Chemistry, Analytical Chemistry, or a related scientific discipline (Master’s degree preferred).
• 3–5+ years of experience in a regulated laboratory environment (e.g., pharmaceutical, biotechnology, or related industry).
• Strong knowledge of analytical techniques such as HPLC, GC, UV-Vis, FTIR, or similar instrumentation.
• Experience with OOS, deviation investigations, and CAPA processes.
• Familiarity with GMP (Good Manufacturing Practices) and relevant regulatory requirements (e.g., FDA, ICH).
• Excellent problem-solving, critical thinking, and analytical skills.
• Strong written and verbal communication skills with the ability to clearly document findings.
• High attention to detail and strong organizational skills.
• Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
• Experience in method validation, method transfer, or stability testing.
• Prior involvement in regulatory inspections or audits.
• Knowledge of statistical analysis tools and trending methodologies.
• Laboratory and office-based role with regular interaction across multiple departments.
• May require occasional extended hours to support critical investigations or deadlines.

Who We Are

Serving customers since 2004, Eagle offers the highest quality in preparation testing for sterility, bacterial endotoxins, microbial detection, beyond-use dating (BUD) determination and active ingredient potency. State-of-the-art equipment, combined with the experience and knowledge of our team, makes Eagle the best choice for all testing needs. The Eagle team is committed not only to performing the best quality control testing, but also working relentlessly with our customers on solutions if tests receive unexpected results. Learn more at www.eagleanalytical.com.

Qualifications

Skills

Preferred

• Detail Oriented
• Advanced
• Behaviors

Preferred

• Team Player: Works well as a member of a group
• Dedicated: Devoted to a task or purpose with loyalty or integrity
• Detail Oriented: Capable of carrying out a given task with all details necessary to get the task done well

Motivations

Preferred

• Self-Starter: Inspired to perform without outside help
• Job Security: Inspired to perform well by the knowledge that your job is safe
• Goal Completion: Inspired to perform well by the completion of tasks
• Ability to Make an Impact: Inspired to perform well by the ability to contribute to the success of a project or the organization

Education

Preferred

• Masters or better in Chemistry or related field.

Experience

Licenses & Certifications

Preferred

• Certification in HPLC

Equal Opportunity Employer