PURPOSE
Primary role is to perform chemical analysis of pharmaceutical products and routine laboratory operations in a cGMP environment. Facility is located in Round Rock, Texas.
Reports to the Quality Control Manager. Internal relationships include Manufacturing, Research & Development, Analytical Development and Quality Assurance.
DUTIES AND RESPONSIBILITIES:
- Conducts routine analysis of raw materials, in-process and finished Drug Substance and Drug Product according to Standard Operating Procedures (SOPs), cGMPs and cGLPs
- Conducts and reviews routine and non-routine analysis of raw materials, in-process materials, Drug Products (API), and Finished Drug Substances and Drug Products according to Standard Operating Procedures (SOPs), cGMPs and cGLPs
- Conducts testing using HPLC, GC, FTIR, UV-Vis and wet chemistry methods under supervision
- Compiles data for documentation of test procedures and prepares reports
- Calibrates and maintains lab equipment. Proactively ensure equipment is calibrated and maintained to minimize disruption to production schedules
- Administers quality control systems according to cGMP and FDA guidelines
- Write and Revise Standard Operating Procedures SOPs
- Ensures proper cGMP/cGLP documentation and maintenance of quality records.
- Participate in method validation and transfer activities.
QUALIFICATIONS (Education, Experience, Knowledge, and Skills):
- Must have a bachelor's degree in a science discipline (Chemistry or pharmaceutical preferred) with at least 3-4 year 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 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 REQUIREMENTS:
- 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.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor employment Visas at this time.
NO RECRUITING AGENCIES PLEASE.