Analytical Chemist II
About The Position
The purpose of this position is to support quality control testing and research and development activities as needed by conducting laboratory testing for raw materials, in-process materials, finished product, and stability samples in accordance with approved analytical methods. This role involves conducting routine and complex laboratory testing, executing laboratory work using best-practice analytical techniques, and adhering to laboratory GDP and cGMP requirements. The position also requires accurate analysis and interpretation of data, peer review of notebooks, data entry, mentoring junior chemists, and assisting in troubleshooting equipment and investigations.
Requirements
- Strong analytical skills, problem-solving ability, and attention to detail.
- Sound understanding of cGMP regulations pertaining to laboratory controls and thorough knowledge of USP compendia standards.
- Ability to read, understand, review, and update Standard Operating Procedures, Forms, and Specifications and assist in designing new procedures as necessary independently, subject to management guidance.
- Ability to perform testing and lead root cause analysis for laboratory investigations for OOS and atypical QC test results, subject to management guidance.
- Ability to effectively communicate within Chemistry Laboratory Staff and Management, as well as other departments.
- Acknowledge and identify continuous improvement opportunities in all work activities. Initiate and follow through to implement, track and achieve on-time completion of testing to support sample release to meet business needs and demands.
- Ability to effectively use a multitude of resources to perform job functions accurately.
- Experience with conducting analysis by FT-IR, UV/Vis spectroscopy, and wet chemistry techniques is required.
- Highly skilled in advanced techniques such as HPLC, GC, and ICP testing, needing little or no guidance and supervision.
Nice To Haves
- 2-5 years of pharmaceutical experience preferred.
- Experience outside of pharmaceuticals in chemistry quality control or R&D will be considered for the highly qualified candidate.
Responsibilities
- Conduct routine and complex laboratory testing for raw materials, in-process materials and samples, finished product samples, and stability samples in accordance with approved analytical methods.
- Conduct and execute laboratory work and testing using best-practice analytical techniques and follow laboratory GDP and cGMP requirements
- Accurately analyze and interpret data using appropriate specifications and test methods.
- Accurately peer review notebooks and verify raw data to support sample release, including data generated in electronic software systems.
- Accurately enter data using appropriate reporting systems and release forms.
- Mentor and train Chemists as needed to support laboratory operations.
- Assist in troubleshooting equipment, analyses, etc.
- Support and contribute to investigation documentation, as needed.
- Relies on instructions and pre-established guidelines to perform job functions.
- Performs other similar duties as required.
- Works under supervision.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
