Quality Control Analyst 2

Quality Control Analyst II in Rensselaer, NY 

Our Rensselaer site is undergoing a crucial quality transformation. This is a rare opportunity to join a highly visible project, re-engineer quality systems from the ground up, and gain unmatched regulatory exposure.

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

1. 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.
2. 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
3. Back up for QC analytical instrument maintenance and calibration
4. Perform QC general laboratory equipment maintenance, laboratory housekeeping and preparation of the laboratory for audits
5. Perform or assist with QC method qualifications, transfers and validations
6. Perform QC method development
7. Perform OOS investigations and lab deviation investigations
8. Provide technical support for shift analysts 
9. Perform cleaning validation studies
10. Assist with the evaluation of new equipment and processes
11. Assist in the review of QC data and provide summaries to management as needed
12. Assist QC Management, as needed, in the completion of OOS, deviations, and CAPAs investigations for QC 
13. 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 

Preferred

·       Experience working in cGMP or GLP pharmaceutical industry environment

Knowledge, skills and abilities

1. 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
2. Ability to meet deadlines and work under pressure with limited supervision
3. Strong time management and organizational skills with the ability to multi-task and manage multiple projects independently 
4. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations 
5. Ability to write reports, business correspondence, and procedure manuals
6. Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations
7. 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
8. Ability to define problems, collect data, establish facts, and draw valid conclusions
9. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
10. Proficient use of computer software, including Microsoft Office Suite and instrument manufacture-based systems
11. Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485 a plus
     

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel as classified. Management reserves the right to revise or amend duties at any time.

Pay Range:  $67,000-$80,000

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

 We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.