QC Analyst

Noven Pharmaceuticals • Miami, FL

2d • Onsite

About The Position

Performs professional, technical laboratory functions. 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, and cleaning verification samples following written procedures and applicable SOPs. This role involves clearly documenting activities performed during testing and calculating and reporting results on applicable specification documents. The analyst will perform physical and chemical analysis using various analytical techniques such as IR spectroscopy, UV-Vis spectroscopy, and chromatographic techniques, adhering to company policies and cGMP requirements. Sample preparation, laboratory record maintenance, and participation in investigations are also key aspects of this role.

Requirements

• Bachelor’s Degree (BA/BS) in Chemistry or related field
• Less than one year testing of chemicals/pharmaceutical products
• Must be able to read and understand analytical procedures
• Must be able to effectively communicate results, problems, or issues, in English verbally as well as in writing
• 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.

Responsibilities

• Performs testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs.
• Clearly documents activities performed during testing and calculates and reports 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level