o Bachelor’s Degree in Chemistry, Life Science or Relevant Field
o Analytical laboratory testing experience (1yr – 2yrs)
o Some experience in an FDA, ISO, DEA or other regulated environment
o Bachelors or Master’s Degree in Chemistry, Life Science or Relevant Field
o Pharmaceutical, OTC quality experience preferred.
o Knowledge of general cGMP requirements.
o Knowledge of general analytical instrumentation (pH, balance, UV-VIS, HPLC, GC)
o Familiarity with chromatography software, LIMs system,
o Familiarity with compendia procedures, such as USP, EP, FCC
o Demonstrates attention to details, time management, and organizational skills.
o Demonstrates good documentation practices
o Excellent communication and interpersonal skills (oral and written).
o Ability to maintain good housekeeping, order, and safety in workplace
GlaxoSmithKline (GSK) Memphis is located in the heart of Tennessee. We are surrounded by “Blues” legends, rich historical landmarks and southern charm. The Memphis site is a part of the Consumer Healthcare supply chain, and is in the Global Manufacturing and Supply Division of GSK. This is a highly automated, state of the art facility that manufactures and packages powders and tablets for oral care, OTC Brands, and medical devices and supports over 17 domestic and international markets. The Memphis site operates 24/7, and is an integral part of the overall supply chain strategy.
The QC lab analyst position supports the manufacturing operation by performing quality control analytical chemistry testing on incoming raw materials, intermediates, bulk product and finished products per approved specifications and procedures.
The individual functioning in the QC Lab Analyst role will be required to utilize numerous pieces of complicated scientific equipment and to interpret the data derived from this instrumentation in the determination of raw material and product status for use in the manufacturing areas or release from the manufacturing groups. The QC Lab Analyst must also be able to capture all raw data generated during the course of testing and present that data in an organized, complete and logical manner. The QC Lab Analyst must also be able to process the data gathered during testing by application of complicated mathematical calculations using scientific calculators or computer-based software. The requirements of GMP and GLP must consistently and continuously be applied through-out this function.
As the QC Lab Analyst role will be required to use complicated scientific instrument systems, there will be mechanical and other issues preventing the continuation of testing. The QC Lab Analyst will be required to have and to develop a base knowledge of the operation of these instruments and to provide basic troubleshooting in an effort to continue with analytical testing. Additionally, the role requires the application of numerous complicated scientific techniques that may at times present with aberrant results. The QC Lab Analyst must be able to review the application of the techniques to demonstrate critical thinking in the determination of a root cause and to make recommendations for corrections based on factual data and information.
The QC Lab Analyst must interact with individuals at all levels of the organization. That interaction must be personable and professional with the ability to communicate the required information at the level appropriate to the audience. Therefore, the QC Lab Analyst must be able to develop strong professional working relationships with Laboratory Management, Senior Laboratory Staff, and with key individuals across the site.
The Quality Control Lab Analyst:
o Develops knowledge of functional area policies and procedures, and performs routine analytical testing functions in the QC laboratory.
o Develops an understanding of applicable Quality System modules, cGMP requirements, laboratory processes and procedures, and other regulatory authority requirements.
o Develops operational proficiency using analytical techniques and instrumentation to support testing for applicable products and raw materials.
o Contributes to projects as assigned and participates in continuous improvement efforts.
o Understands established internal and external customer expectations and maintains effective communication pathways.
o Develops a working knowledge of applicable departmental policies and procedures.
o Performs routine analytical testing in cGMP laboratory environment according to written procedures and test methods.
o Develops thorough knowledge as data checker and reviewer accountability.
o Develops a thorough knowledge of regulations and requirements of applicable cGMP’s, Quality System modules, FDA Guidance Documents, and other regulatory authority requirements.
o Maintains effective communication processes with key customers and project managers
o Works independently and/or in a team environment to meet or exceed established objectives, applicable Key Performance Indicators (KPI’s) and Quality Performance Indicators (QPI’s).
Functional Area Responsibilities - Analytical Chemistry Product and Raw Material Testing.
o Develops operational proficiency for analytical test methods for finished product, intermediates and raw materials
o Develops proficiency using analytical chemistry wet methods and instrumentation according to the defined training program.
o Develops a clear understanding of USP compendia, and proprietary test methodology.
You may apply for this position online by selecting the Apply now button.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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