Job Details
Job Description
Job Summary
The Scientist 3 - QC is responsible to perform testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculate and report results on applicable specification documents, participate in method transfer activities within departments or between facilities or organizations. This role will also provide feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture.
Essential Functions
- Performs physical and chemical analysis of raw materials, in-process and finished pharmaceutical products, including products on stability, according to written methods or compendial methods as applicable, material specifications, using analytical techniques such as IR spectroscopy, UV-Vis spectroscopy, and chromatographic techniques adhering to company policies as identified in standard operating procedures (SOPs).
- Actively participate in any project work as and when assigned. Perform process validation and cleaning validation/verification testing on various drugs. Assist other scientists with analytical, instrument and software related problems as required.
- Use sonic sifter, laser diffraction, Karl Fischer, UV-Vis spectrophotometer, Infra-red spectrophotometer, HPLC with UV detection as well as with conductivity detection, TLC, pH meter, and dissolution. Calibrate HPLC, Dissolution apparatus equipped with auto-sampler and /or in-line UV, pH meters, analytical balances, and Karl-Fischer titrator.
- Document steps followed during analysis execution, calculate and report results. Actively participate in investigation of laboratory results.
- Review laboratory analysis data for completeness, specification compliance, and compliance with company s written policies.
- Report any abnormal findings to the Supervisor. As assigned, perform in-depth review of analytical records/reports to assure that calculations and other data are technically correct and compliant to relevant specifications.
Additional Responsibilities
- Assist the laboratory supervisor with handling non-routine special projects requiring activities such as out-of-specification investigations and out-of-alert limit investigations in the laboratory.
- Ensure that expired chemicals and reference standards are removed from laboratory area.
- Perform calibration of HPLC, GC, and other equipment as assigned by the supervisor.
- Assist with hands-on training of newly hired Technicians or Scientists 1 and 2 levels.
Qualifications
Education
- Bachelors Degree (BA/BS) Chemistry or related science discipline - Required
Experience:
Work Experience
1-5 years or more testing of chemicals/pharmaceutical products - Preferred
Skills And Abilities
- Must be able to read and understand analytical procedures. - Intermediate
- Must be able to effectively communicate results, problems or issues, verbally as well as in writing. - Intermediate
- Must be computer literate. - Intermediate
- Must be capable of maintaining clear and concise laboratory records and communicating clearly both within and between departments. - Intermediate
- Must be precise and consistent in day-to-day analysis, easily trainable, and ready to learn. - Beginner
- Must be able to work in a team environment and be flexible to easily adapt to changes in assignments. - Beginner
- Must follow safe practices as identified in appropriate MSDS during working with chemicals, and must follow applicable state and federal regulations. - Beginner
Specialized Knowledge
- Must possess a working knowledge of analytical chemistry techniques, such as analytical weighing, quantitative transfer, preparation of quantitative solutions, analytical dilutions, spectrophotometric analytical techniques, dissolution and drug release, disintegration, moisture determination (Karl Fischer, Coulometric, LOD), thin-layer chromatographic technique, gas chromatographic techniques, HPLC, and measuring physical parameters (bulk and tapped densities, and particle size by sieve analysis).
- Must be able to follow compendial (USP/EP/BP/JP) procedures for wet chemical tests.
- Must understand and apply cGMP requirements applicable to quality control laboratory.
About Us
Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.