Quality Control Analyst II
45 New York Avenue, USMA010C Framingham, MA
This Quality Control Analyst II is responsible for performing routine and complex testing of in-process samples, stability samples and final products in accordance with SOPs for product release and validation.
- Perform UV-Vis spectrophotometry, HPLC, UPLC, and Gel assays for in-process and final product samples.
- Perform maintenance on complex laboratory equipment including HPLC, UPLC and GC systems.
- Review of QC Data for compliance to procedures and specifications.
- Calculate and evaluate results.
- Participate in training of less experienced staff.
- Transfer methods from support groups to the QC laboratory.
- Author protocols and technical reports related to the implementation of QC equipment.
- Effectively demonstrate an understanding of cGMPs and application to specific responsibilities:
- Follow accurate written procedures for testing of in-process and final product samples.
- Communicate inter-departmentally and with outside contacts to solve technical issues.
- Exercise sound judgment and decision making when problem solving.
- Revise standard operating procedures as needed.
- Work independently under general supervision and direction.
- Work in compliance with cGMPs.
- Practice safe work habits and adhere to safety procedures and guidelines.
- Experience with Dionex, GC, HPLC, Gel Electrophoresis, UV Vis Spectroscopy and wet Chemistry.
- Experience with Empower software.
- Knowledge of lab-based data management systems.
- Bachelor' s Degree in Life Sciences discipline and 3-6 years’ experience in cGMP lab environment, or a
- Master' s Degree in Life Sciences discipline and 1-year experience in cGMP lab environment.
- Proficient in Outlook and Microsoft Word and Excel and lab-based data management systems.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.