Analytical Chemist I

Description

The Quality Control Laboratory Analyst supports Quality Control testing and Research & Development activities by performing routine laboratory testing of raw materials, in-process materials, finished products, and stability samples. This role ensures all testing is conducted in accordance with approved analytical methods, laboratory procedures, and applicable regulatory standards.

• Perform routine laboratory testing for raw materials, in-process materials, finished product samples, and stability samples according to approved analytical methods and specifications.
• Prepare samples and reagents and operate laboratory equipment required for testing procedures.
• Conduct laboratory work using best‑practice analytical techniques.
• Ensure all testing activities comply with laboratory Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP).
• Follow established standard operating procedures (SOPs), analytical methods, and laboratory safety protocols.
• Analyze and interpret laboratory data using appropriate specifications and test methods.
• Investigate and report any out‑of‑specification (OOS) or atypical results according to established procedures.
• Maintain accurate laboratory records and documentation in compliance with regulatory and company requirements.
• Enter testing results into laboratory reporting systems and complete sample release forms as required.
• Perform peer review of laboratory notebooks, worksheets, and electronic records to verify accuracy and completeness of data supporting sample release.
• Perform work under supervision using established procedures and pre‑defined guidelines.
• Support laboratory and quality operations as assigned.
• Perform other related duties as required to support departmental objectives.

• Strong analytical skills, problem‑solving ability, and attention to detail.
• Understanding of cGMP regulations pertaining to laboratory controls and knowledge of USP standards.
• Ability to read, understand, review, and update Standard Operating Procedures, Forms, and Specifications and assist in designing new procedures as necessary under management guidance.
• Ability to perform testing for laboratory investigations for OOS and atypical QC test results under management guidance.
• Effective communication within Chemistry Laboratory Staff and Management.
• Identification of continuous improvement opportunities in all work activities.
• Effective use of a multitude of resources to perform job functions accurately.

• BS or MS in Chemistry, Biochemistry, or related field required with 0–3 years of pharmaceutical experience preferred. Experience outside of pharmaceuticals in chemistry quality control or R&D will be considered for the highly qualified candidate.
• Experience with conducting analysis by FT‑IR, UV/Vis spectroscopy, and wet chemistry techniques is required.
• Experience in more advanced techniques such as HPLC and GC is preferred.

• This position requires bending, typing, lifting (up to 40 lbs.), standing, sitting and walking throughout the facility.
• This position encounters the following environmental factors: hazardous materials including HPLC solvents, chemical reagents, acids, and other non‑specified hazardous materials that are project specific.
• This position requires safety glasses and other non‑specified personal protective equipment to be worn as necessary.