Duration: 3/6 months plus, temp to hire, have converted early or have kept them on past 1 year
JOB SUMMARY:
Individuals 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 within the clients rules and regulations
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 clients 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.
QUALIFICATIONS:
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
PHYSICAL REQUIREMENTS:
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