Job Description

Job Description

Primary role is to perform chemical analysis of pharmaceutical products and routine laboratory operations in a cGMP environment.

Reports to the Quality Control Manager. Internal relationships include Manufacturing, Research & Development, Analytical Development and Quality Assurance.

DUTIES AND RESPONSIBILITIES

Analytical Testing & Review

• Conduct and review routine and non-routine analysis of raw materials, in-process materials, APIs, and finished products in compliance with SOPs, cGMPs, and cGLPs.
• Perform testing using HPLC, GC, GC-MS, ICP-MS, FTIR, UV-Vis, and wet chemistry methods.
• Participate in method validation and method transfer activities.

Equipment & Instrumentation

• Calibrate, maintain, and troubleshoot laboratory equipment to ensure operational readiness.
• Proactively prevent production delays through scheduled maintenance.
• Maintain expert knowledge of instrument components and functionality.

Documentation & Compliance

• Compile and interpret data, document test procedures, and prepare reports.
• Administer quality control systems in compliance with FDA guidelines.
• Write and revise Standard Operating Procedures (SOPs).
• Ensure thorough cGMP/cGLP documentation and maintenance of quality records.

Leadership & Team Development

• Provide clear direction, coaching, and mentoring to team members to enhance skills and performance.
• Foster a culture of accountability, integrity, and continuous improvement.
• Demonstrate strong decision-making skills in prioritizing work under changing deadlines.
• Lead by example in quality, safety, and compliance standards.
• Encourage cross-functional collaboration to resolve technical challenges.
• Take ownership of special analytical projects, including authoring protocols and reports.

QUALIFICATIONS

• Bachelor’s degree in a science discipline (Chemistry or pharmaceutical preferred) with a minimum 3-4 years hands-on laboratory experience in FDA regulated industry or associate degree with 7-10 years of hands-on laboratory experience in GMP environment, or equivalent.
• Strong background in principles of separation using analytical instrumentation such as HPLC, GC, UV/VIS in a GMP environment.
• Expert knowledge of ICH and FDA guidelines.
• Expertise in Chromatographic Data Acquisition and LIMS Systems experience such as ChemStation (OpenLab), Chromeleon, or Empower 3.
• Attention to details in collecting data and accurately maintaining laboratory notebooks required.
• Drug Screen and DEA Background check required.

WORKING CONDITIONS/PHYSICAL REQIUREMENTS

• Must be able to conduct visual inspections of incoming materials to verify appearance and printed content (e.g. product labels) meet product specifications.
• Must accurately distinguish different colors for reporting of appearance and colorimetric tests.
• Occasional lifting of up to 50 lbs.
• Annual occupational medical assessment required to ensure ability to meet position requirements and based on site requirements.

WORKING HOURS

• Monday - Friday

LOCATION

This position is located in Round Rock, Texas. Rock Round is located 15 miles north of Austin, TX.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

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