QC Analyst I

Curia•City of Rensselaer, NY

18h•$50,000 - $63,575•Onsite

About The Position

The Quality Control Analyst I is responsible for performing routine and non-routine analytical chemistry assays of raw materials, in-process samples, finished APIs, and stability samples. This role also participates in special projects, method development/transfers and cleaning study qualifications. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This is an off-shift position. May occasionally require work on flexible schedule from second and third shift. Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

Requirements

Bachelor’s degree in Chemistry or related field
Minimum 0-3 years’ pharmaceutical experience or equivalent combination of education and experience
Excellent verbal and written communication skills, including the ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
Ability to meet deadlines and work under pressure with limited supervision
Strong time management and organizational skills with the ability to multi-task and manage multiple projects independently
Ability to read, analyze, and interpret, professional journals, technical procedures, or governmental regulations
Ability to write reports, business correspondence, and procedure manuals
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations
Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis
Ability to define problems, collect data, establish facts, and draw valid conclusions
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
Proficient use of computer software, including Microsoft Office Suite and instrument manufacture-based systems
Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485 a plus

Nice To Haves

Experience in a cGMP or GLP pharmaceutical industry environment

Responsibilities

Perform analytical testing for incoming, in-process, raw material and final products, and stability samples using equipment such as balances, pipettes, pH meter, UV/Visible spectrophotometer, Total Organic Carbon analyzer, etc.
Perform chromatography (Liquid/GC) after extensive qualification and training
Perform wet chemistry assays
Regularly perform water sample collection
Back up for QC analytical instrument maintenance and calibration
Performance of QC general laboratory equipment maintenance, laboratory housekeeping and preparation of the laboratory for audits
Assist in the review of QC data and provide summaries to management as needed
Assist QC Management, as needed, in the completion of OOS, deviations and CAPAs investigations for QC
Backup for QC analytical sample receipt for internal testing, outside laboratory testing, login, processing, shipment, tracking, distribution of test results, and closure