Analytical Chemistry Investigation Lead - CAPA & OOS

BioSpace; Houston (TX); Sur place; USD 95 000 - 125 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Analytical thinking

Problem solving

Strong communication

Detail oriented

Multitasking

GMP knowledge

Regulatory awareness

Cross-functional collaboration

Documentation skills

Time management

Formation

Bachelor's in Chemistry/Analytical Chemistry

Master's degree preferred

Outils

HPLC

GC

UV-Vis

FTIR

Description du poste

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.