QC Analyst I

Quality Control Analyst I - Onsite position in Rensselaer, NY - 12 Hour Nights

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. 

We proudly offer

• Generous benefit options 
• Paid training, vacation and holidays 
• Career advancement opportunities 
• Education reimbursement
• 401k program
• And more! 

Supervisory Duties

This position does not have supervisory responsibilities.

Essential job duties

1. 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.
2. Perform chromatography (Liquid/GC) after extensive qualification and training
3. Perform wet chemistry assays
4. Regularly perform water sample collection
5. Back up for QC analytical instrument maintenance and calibration
6. Performance of QC general laboratory equipment maintenance, laboratory housekeeping and preparation of the laboratory for audits
7. Assist in the review of QC data and provide summaries to management as needed
8. Assist QC Management, as needed, in the completion of OOS, deviations and CAPAs investigations for QC
9. 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 0-3 years’ pharmaceutical experience or equivalent combination of education and experience

Preferred

• Experience in a 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, 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

Physical requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to stand; walk; or sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with