Perform chemical testing of raw materials, intermediates, and Active Pharmaceutical Ingredients (APIs) in support of process research, discovery research, GMP production, and stability testing. Responsible for utilizing common analytical techniques such as: HPLC, GC, UV-Vis, LC-MS, KF, FTIR, NMR, Refractive index, and wet chemical methods such as titrations. Execute routine analysis, with direction on more complicated analysis, method development, and project management.
- Apply basic scientific knowledge to perform analysis and to solve simple analytical problems.
- Learn and follow all Standard Operating Procedures (SOPs) and Good Manufacturing Practices. (GMPs)
- Revise SOPs, test methods, and GMP documents with guidance.
- Conduct analysis and interpret results.
- Transfer, modify, and improve analytical methods with guidance from experienced team members.
- Prepare scientific reports with guidance from experienced team members.
- Review all data regarding raw materials, intermediates, and APIs.
- Performs testing for the qualification of reference standards.
- Perform cleaning validations and verifications.
- Calibrate instruments and contribute to laboratory organization and compliance.
- Other duties as assigned.
- Demonstrates technical proficiency and self-assuredness in applying cGMP standards.
- Applies cGMP concepts in association with department specific responsibilities.
- Ensures all documentation produced is in compliance with cGMP standards.
- Responsible for contributing to audit readiness and for participating in quality audits with FDA, other Regulatory Agencies, and customers, as needed.
- Ensures work is in compliance with all state and federal regulations, including but not limited to GMP, DEA, FDA, etc.
ENVIRONMENTAL, HEALTH, & SAFETY RESPONSIBILITIES
- Follows and abides by all EH&S policies, practices, and procedures in association with department specific responsibilities.
- Demonstrates technical and procedural proficiency and self-assuredness in applying EH&S standards.
- Responsible for contributing to audit readiness and for participating in EH&S audits with internal Company groups, regulatory agencies, and customers.
- Responsible for reporting all near misses, accidents, and dangerous occurrences through the appropriate Company procedures to ensure an investigation is initiated.
- Cooperate with all root cause investigations and follow corrective actions and compliance with Company policies and procedures, and all state and federal regulations occurs within department.
- Support the Company’s commitment for environmental health & safety by applying ISO 14001, OHSAS 18001, and Sustainability 2025 principals into daily activities.
PHYSICAL DEMANDS & WORK ENVIRONMENT
- While performing the duties of this job it is required to stand, walk, and use hands to operate objects, tools, or controls; reach with hands or arms; climb, balance, stoop, kneel, or crouch when necessary for job activity.
- Must be able to lift and/or move up to 50 pounds.
- Specific vision abilities include: near, distance, peripheral, color perception, and the ability to adjust focus.
- Regularly works with moving mechanical parts and may work with toxic or caustic chemicals. The work may be performed in humid areas with low or high temperatures.
QUALIFICATIONS, KNOWLEDGE, & EXPERIENCE
- High School Diploma or equivalent with 3-5 years related experience in analytical chemistry or pharmaceutical Quality Control environment.
- BS in Analytical Chemistry or equivalent with 0-3 years related experience in a pharmaceutical Quality Control environment.
- Experience with common analytical techniques such as: NMR, UV, pH meter, KF, FTIR, Refractive index.
- Ability to read, analyze, and interpret English-language chemical periodicals, scientific journals, and regulatory documents.
- Ability to write clear and concise technical reports.
- Ability to work independently with minimal supervision and in a team environment.
- Good written and verbal communication skills. Experience communicating effectively to management.
- Good understanding of Microsoft Office and statistical software.
- Demonstrate ability to exercise good judgment and make decisions quickly
- Experience in establishing integrated plans with resource and task constraints.
- Experience with common analytical techniques such as: HPLC, GC, LC-MS.