Quality Control Senior Associate # JN -062021-66350
West Greenwich, Rhode Island
Posted on: June 30, 2021
Industry: QA Testers
Job Number: JN -062021-66350
Description:
Job Details:
- Under general supervision, this position will perform routine procedures and HPLC/UPLC testing in support of routine and stability samples for multiple drug substance programs
Specific responsibilities include:
- Performing routine laboratory procedures, such as performing analytical testing and review for HPLC/UPLC assays, troubleshooting, solving problems and communicating with stakeholders
- Will also be responsible for documenting, computing, compiling, interpreting, reviewing, and entering data
- Additional responsibilities include providing and communicating results, maintaining/operating specialized equipment, and initiating and/or implementing changes in controlled documents
- Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, laboratory notebooks, written procedures, building monitoring systems and laboratory log books
Preferred Qualifications:
- 4-6 years of experience in performing HPLC/UPLC assays.
- Demonstrated experience in investigations and QC processes
- Self-motivated, strong organizational skills and ability to manage multiple tasks at one
- time with minimal supervision
- Strong communication skills (both written and oral), facilitation and presentation skills
- Understanding and application of principles, concepts, theories and standards of GMP
- QC analytical laboratories
- Understanding of biopharmaceuticals process and related unit operations
- Strong analytical skills with the ability to collect, organize, analyze, and disseminate
- significant amounts of information with attention to detail and accuracy
- Independent, self-motivated, organized, able to multi-task in time-sensitive
- environments