QC Analyst (Biotech)

Performs professional, technical laboratory functions.

Responsibilities

• The QC Analyst I - is an entry-level role in the analytical Quality Control 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.
• Performs physical and chemical analysis of raw materials, components, 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 in compliance with cGMP and current safety regulations.
• Creates and maintains laboratory record documentation in compliance with regulatory requirements.
• Actively participates in investigation of laboratory results, when required.
• 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.

Qualifications

Competencies:

 

Education / Experience:

• Bachelor's Degree (BA/BS) in Chemistry or related field – Required.
• Less than one year testing of chemicals/pharmaceutical products – Required.
• Must be able to read and understand analytical procedures – Required.
• Must be able to effectively communicate results, problems, or issues, in English verbally as well as in writing – Required.
• Must be computer literate.
• Must be precise and consistent in day-to-day analysis, easily trainable, and ready to learn.
• Must be able to work in a team environment and be flexible to easily adapt to changes in assignments.
• Must follow safe practices as identified in appropriate SDS while working with chemicals and must follow applicable state and federal regulations.
• 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.

 

Judgment / Decision Making:

Duties are performed within framework of departmental or functional guidelines, requiring interpretation and original thinking.

 

Work Environment:

A laboratory environment with exposure to chemicals, caustics, fumes, heat and electrical current.

 

Physical Demands:         

Visual acuity and manual dexterity required to operate computer, analytical instrumentation, sample preparation. Majority of time spent standing. Often required to lift objects weighing up to 20 pounds.