Quality Control Chemist

Role Summary

Quality Control Chemist at Teva. Performs testing and analysis of incoming materials, intermediates, finished products, swab samples, and other samples to support commercial and development activities in compliance with regulatory requirements and company procedures.

Responsibilities

• Testing and analyzing incoming materials such as intermediates, finished products and swab samples.
• Preparing, maintaining and reviewing records and documentation on solutions, sample preparation and investigational/experimental samples.
• Supporting laboratory investigations into Out of Specification/Out of Trend results or other laboratory events.
• Revising documentation such as Standard Operating Procedures, Test Methods and Specifications.
• Coordinating and sending materials for contract laboratory testing.
• Compliance with DEA and site requirements regarding handling, use and disposal of controlled substances.
• Verifying compendial methods.
• Providing training to other analysts on activities they have developed expertise in.
• Peer review of documents as part of potential full-time responsibilities.
• Assisting with stability program activities including sampling and statistical analyses.
• Assisting with sampling of incoming materials as needed.
• Maintaining work areas and performing duties safely and efficiently in line with cGMP, SOPs and Batch Records.
• Performing additional related duties as assigned.

Qualifications

• Requires a Bachelor‚Äôs degree, preferably in Chemistry or Microbiology, or equivalent education/experience with a minimum of 2 years relevant progressive experience in a Quality Control Laboratory environment.
• Solid understanding of analytical chemistry principles as applied to HPLC, GC, FTIR, UV-Vis and other techniques.
• Working knowledge of cGMP, DEA and other regulatory requirements related to pharmaceutical production (preferred).
• Experience with Laboratory Information Management Systems (Labware LIMS and/or Empower preferred).

Skills

• Proficiency with MS Office, LMS, ERP systems (SAP/Oracle) and quality systems (LIMS, Trackwise, Qdocs).
• Strong technical writing and documentation skills.
• Effective written and oral communication; ability to collaborate with internal stakeholders.
• Self-directed, organized, and able to prioritize work.
• Detail-oriented with ability to identify errors and inconsistencies.

Education

• Bachelor‚Äôs degree in Chemistry or Microbiology or equivalent; minimum 2 years in QC laboratory environment.

Additional Requirements

• Physical requirements include sitting/standing for extended periods, fine motor skills for handling samples and equipment, and lifting up to 25 lbs as needed.
• Working environment may involve exposure to fumes, odors, dusts, mists, gasses, moving parts; PPE may be required.