Scientist I, Quality Control Technical Services

Job Summary

The Scientist 1 - QCTS is an entry level, and it contributes to tasks associated with qualifications and method validations for active pharmaceutical ingredients, excipients, and the finished product pharmaceutical dosage forms.

The individual is also 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

Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, according to written methods, protocols, material specification, and company policies as identified in standard operating procedures (SOPs) to support method validation / verifications.

Comply with CGMPs, SOPs, and STPs to avoid out-of-specification situations. Assure compliance with state and federal regulations.

• Utilize techniques of Spectrophotometry, HPLC, GC, dissolution, and wet chemistry tests in accordance with the USP.
• Actively participate in any project work as and when assigned. Creates and maintains laboratory record documentation and interpret and communicate analytical results.
• Report any abnormal findings to the Supervisor. Actively participates in investigation of laboratory results, when required.

Contribute to technical problem solving and troubleshooting as needed.

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 the laboratory area. Performs ordering of new projects reference standards, chemicals and HPLC, GC columns.

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.
30+ days ago