Analytical Lab Scientist (Compliance)

Job Title:

Analytical Lab Scientist, Compliance

Job Location:

San Antonio, TX (On-site – Analytical Laboratory)

Employment Type:

Full-time

Compensation:

$120,000 – $180,000

We are hiring on behalf of a client, an advanced analytical testing laboratory supporting modern compounding pharmacies and healthcare partners. They are seeking a highly skilled

Analytical Lab

Scientist, Compliance

to lead laboratory quality, compliance, and testing excellence.

Overview

Our client operates at the forefront of analytical testing, delivering precise and reliable data through advanced instrumentation and scientifically rigorous processes. Their work supports high-sensitivity testing, stability analysis, and structured reporting, ensuring confidence and integrity in every result.

Position Summary

The

Analytical Lab Scientist, Compliance

will play a critical leadership role in developing, validating, and executing analytical testing for compounded drug products. This individual will serve as the steward of laboratory quality systems, ensuring strict adherence to regulatory standards while maintaining the highest levels of data integrity.

You will act as a subject matter expert during audits, lead compliance initiatives, and foster a quality-first culture across laboratory operations.

Key Responsibilities

Analytical \& Microbiological Testing

• Perform potency, purity, sterility, and endotoxin testing
• Utilize advanced instrumentation such as HPLC and LC-MS/MS

Method Development \& Validation

• Develop and validate analytical methods aligned with USP and FDA standards
• Ensure compliance within 503A and 503B regulatory frameworks

Compliance \& Quality Leadership

• Oversee QC data and ensure adherence to USP \<795\>, \<797\>, \<800\> and cGMP standards
• Maintain and enforce laboratory quality systems

Audit \& Regulatory Management

• Act as SME during FDA and State Board inspections
• Represent laboratory data integrity and compliance practices

Deviation \& CAPA Management

• Lead OOS/OOT investigations
• Implement effective corrective and preventive actions

Instrumentation \& Data Integrity

• Operate LC-MS/MS and other advanced systems
• Ensure documentation aligns with ALCOA\+ principles

SOP Development \& Process Optimization

• Draft, review, and enforce SOPs
• Improve workflows while maintaining accuracy and compliance

Required Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, or a related field
• 2–5\+ years of experience in pharmaceutical, analytical lab, or compounding environments
• Hands-on experience with HPLC and/or LC-MS/MS
• Strong knowledge of USP \<795\>, \<797\>, \<800\> and FDA 503A/503B guidelines
• Experience with quality control, audits, and regulatory compliance
• Proven expertise in data integrity (ALCOA\+, LIMS, or structured reporting systems)

Why Apply?

• Opportunity to work in a high-impact, compliance-driven laboratory environment
• Exposure to advanced analytical technologies and regulatory frameworks
• Clear growth potential within a fast-scaling organization
• Competitive compensation and strong leadership exposure

If you’re a detail-oriented scientist who thrives in a regulated environment and is passionate about quality and compliance, we encourage you to apply.

Apply now or reach out directly for more details.