Are you well-versed in quality control and analytical methods within small molecule production? Looking to find an exciting role within a well-established and respected biotech/pharma company? This could be the perfect next step in your career!
What You'll Do:
The Senior Quality Control Analytical Scientist will play a cornerstone role in the development, characterization, validation, and implementation of analytical methods for the manufacture of both new and current products that are used in life science research and medical devices, as well as Active Pharmaceutical Agents (API) in a brand new CMC facility. Some of the key responsibilities include:
Perform analytical method validation and characterization when required to support process improvement, product transfer, or new product realization projects.
Be able to independently perform all aspects of method development and method validation; product and raw material testing are also a function of this position.
Develop reports, protocols, and SOPs for new and current analytical methods.
Mentor and train junior scientists and aid when needed in high throughput times of intermediate testing, final product and raw materials.
Maintain a working knowledge of QC Lab instrumentation and associated analytical methods utilized for product release testing. Perform analytical method evaluation and/or re-validation upon request, as part of Installation / Operation / Performance Qualification efforts related to new or changed laboratory instrumentation.
Evaluate and interpret analytical testing results. Act as primary reviewer of analytical data generated from raw materials test, in process testing, and final product testing.
Perform laboratory investigations for Out of Specification results or other testing abnormality. Investigate complaints from customers and internal deviations/nonconformances as assigned.
Develop and maintain a product / intermediate stability program.
Report results of release testing according to company Quality System requirements. This includes the input of results into SAP Quality Module and issuing COA’s as needed.
Prepare and/or maintain QC testing materials, retention samples, and reference standards.
Write, review and revise, as necessary, Inspection Plans, test methods, SOPs and other QC Dept procedures, for accurate and complete content and ensuring they meet documentation policy.
Provide training on QC methods and instrumentation in the laboratory as needed.
Understand and comply with ethical, legal and regulatory requirements applicable to the business.
What You'll Bring:
Degree in Chemistry or related Lab Science: Master's with 2-4 years of experience, or a Bachelor's with 4-7 years of direct experience in a Quality Control lab using advanced equipment and techniques.
Extensive experience in Method Validation.
High level of knowledge on the use and troubleshooting of typical analytical instruments, including GC, ICP-OES, LC-MS, HPLC, NMR, Extinction Coefficients and Karl Fisher.
Working knowledge of, and the ability to independently determine, solubility, viscosity, TGA Fluorescence, mass and conductivity.
Knowledge of basic descriptive statistics such as mean, standard deviation, confidence intervals and linear regression, including experience with the use of statistical tools to analyze data.
Proven track record in the design of new and existing product method development.
PREFERRED BUT NOT REQUIRED QUALIFICATIONS:
MS with 5-7 years of experience in method development and validation using HPLC, Mass Spectrometer, LC-MS, NMR, ICP-OES, GC, NMR, Spectrophotometers or Luminometers.
Experience or familiarity with ISO9001 requirements.
Independent, self-starter with proven results in problem identification, planning, communication and project management.
Desire for future growth into QC Department Leader / Supervisor.
Organizational and multi-tasking skills; able to manage several tasks simultaneously.
This position includes physical demands such as working with chemical reagents required for analytical testing, having the ability to identify and distinguish colors used in testing, wearing and using personal protective equipment, and traveling as needed.
The annual base compensation range for this position is anticipated to be between $70,000 – $100,000 per year.
Take the next big step in your career and Apply Now!
Questions? Contact Andie Veach directly at Andie@CarexScientific.com
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