Quality Control Analyst II Job Rensselaer New York USA,Quality Assurance

Location: Rensselaer

Quality Control Analyst II in Rensselaer, NY - Nights

Build your future at Curia, where our work has the power to save lives

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives.

We proudly offer:

Generous benefit options (eligible first day of employment)
Paid training, vacation and holidays (vacation accrual begins on first day of employment)
Career advancement opportunities
Education reimbursement
401K program with matching contributions
Learning platform
And more!

Position overview

The Quality Control Analyst II 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.

Essential job duties

Perform analytical testing for incoming, in-process and final products, and stability samples using equipment such as balances, pipettes, pH meter, UV/Visible spectrophotometer, Total Organic Carbon analyzer, etc.

Perform chromatography (HPLC/GC, UPLC) with minimal qualification and training, wet chemistry assays, analytical chemistry assays, HPLC, GC, IR, UV, etc. and raw material testing and/or sampling

Back up for QC analytical instrument maintenance and calibration

Perform QC general laboratory equipment maintenance, laboratory housekeeping and preparation of the laboratory for audits

Perform or assist with QC method qualifications, transfers and validations

Perform QC method development

Perform OOS investigations and lab deviation investigations

Provide technical support for shift analysts

Perform cleaning validation studies

Assist with the evaluation of new equipment and processes

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

Education, experience, certification and licensures Required

· Bachelor's degree in Chemistry or related field

· Minimum 3-5 years' experience in pharmaceutical industry environment or equivalent combination of education and experience

Knowledge, skills and abilities

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 general business periodicals, 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…