Job Title: Scientist - Quality Control
Individual will perform testing of raw materials, in process samples, finished products, stability samples and cleaning samples in support of release of materials. Additionally, this position will support other activities associated with laboratory operation and will review data for compliance, review policy and procedure documents as necessary to meet cGMP regulations and applicable guidelines. Perform training of other scientists on standard analytical techniques. Must be able to work in a complex, fast paced environment with an ability to prioritize.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Conducts daily activities in accordance with Company's Cardinal Rules
- Perform testing of raw materials, in process samples, finished products, stability samples and cleaning samples in support of release of materials while striving to adhere to assigned due dates.
- Provide project support through defined testing requests, compilation of data and reporting of findings to supervisor and / or project lead including issues/abnormal observations while striving to adhere to assigned due dates.
- Perform technical and compliance review of complex analytical tests.
- Execution of testing protocols without deviation.
- Willingness to work on Safebridge Category I-III compounds.
- Perform training of other scientists on standard analytical techniques.
- Requires full understanding of at least one instrument including functionality and the ability to troubleshoot issues.
- Maintain analytical equipment (periodic calibration and maintenance) in accordance with PI policies and procedures.
- Maintain files as directed.
- Perform data entry into spreadsheets and proprietary computer systems.
- Operate following policies and procedures to meet cGMP regulations and ICH guidelines.
- Maintain documentation in an accurate, clear and concise manner in accordance to company policies and procedures.
- Maintain a clean, safe and orderly workplace, following all applicable EHS policies and procedures.
- BS degree in chemistry or biology or related field
- 2+ years of experience in a GMP analytical laboratory
- Accurate Documentation and Observation skills
- Working knowledge of the cGMP regulations preferred
- Working knowledge of safe handling practices of dangerous chemicals
- Computer skills (spreadsheet, database and word processing window based programs)
- Hands-on experience with the operation and maintenance of analytical instrumentation preferred. (Polarimetry, pH and conductivity meters, Automatic titrators, TOC, HPLC or GC using Empower)
- Excellent Communication skills
- Must have good hearing and sight - adequate for safety programs in a pharmaceutical manufacturing plant
- Must be able to sit and/or stand for extended periods
- Ability to work effectively under pressure to meet deadlines
- Frequent sitting, standing, walking, climbing of stairs, use of computer monitor screen, talking, writing, listening
- Must be able to lift 25 lbs. or occasionally lift up to 35 lbs.
- Ability to wear proper safety equipment when working in the laboratory or plant