Scientist I, Quality Control (Biotech)

Job Summary

The Scientist I - QC is an entry-level role responsible for performing testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, to clearly document activities performed during testing and to calculate and report results on applicable specification documents.

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).
• Prepares samples for analysis involving thorough cleanliness and complex steps for analysis using chromatographic techniques and other analytical techniques as applicable.
• Creates and maintains laboratory record documentation (notebooks and computer-based), documents exact steps followed during analysis execution, calculates and reports results in a timely manner.
• Actively participates in investigation of laboratory results, when required.

Additional Responsibilities

• Assists, as and when needed, scientists working in the laboratory.
• Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.
• Performs calibration of dissolution apparatus, FT-IR, UV-Vis spectrophotometer, HPLC as assigned by the supervisor.
• Prepares volumetric test solutions following USP or in-house methods for wet chemical tests, standardizes such solutions as required, standardizes API for use as in-house reference standard as assigned.

Education

Bachelors Degree (BA/BS) in Chemistry or related field - Required

Work Experience

Less than one year testing of chemicals/pharmaceutical products - Required

1 year 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.