Benuvia
PURPOSE
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). Investigate and document Deviations and Out of Specification (OOS) events. Provide guidance on CAPAs related to adverse quality events where applicable. 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 Bachelors degree (B.S.) in Chemistry or a closely related scientific discipline with a minimum of five (5) years of experience in FDA-regulated laboratories, or Masters degree (M.S.) in Chemistry or a closely related scientific discipline with a minimum of three (3) years of experience in an FDA-regulated laboratory environment. Strong background in principles of separation using analytical instrumentation such as HPLC and GC 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 legally authorized to work in the U.S. Visa sponsorship is not available at this time.
Positions posted for Benuvia Operations are not open to third party recruiters or agencies. Unsolicited resumes for these positions will be considered to be free referrals.
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). Investigate and document Deviations and Out of Specification (OOS) events. Provide guidance on CAPAs related to adverse quality events where applicable. 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 Bachelors degree (B.S.) in Chemistry or a closely related scientific discipline with a minimum of five (5) years of experience in FDA-regulated laboratories, or Masters degree (M.S.) in Chemistry or a closely related scientific discipline with a minimum of three (3) years of experience in an FDA-regulated laboratory environment. Strong background in principles of separation using analytical instrumentation such as HPLC and GC 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 legally authorized to work in the U.S. Visa sponsorship is not available at this time.
Positions posted for Benuvia Operations are not open to third party recruiters or agencies. Unsolicited resumes for these positions will be considered to be free referrals.