Quality Control Senior Associate # 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