Quality Control Analyst
Newark Metro Area, NJ
Responsibilities for an Associate Scientist include, but are not limited to, the following:
Contributes to the development of priority drug candidates through the development, validation, and implementation of analytical methods involving modern analytical instrumentation including HPLC/UPLC, GC, dissolution, FT-IR, Karl Fischer titrations, etc.
Transfers validated methods to customer labs, and partner-owned quality control (QC) labs.
Performs testing for development and clinical materials and stability samples in accordance with established methods, specifications and protocols under supervision.
Knows the fundamentals of analytical methodology and can troubleshoot instrumentation and method performance issues of routine complexity.
Documents / reviews laboratory work using laboratory notebooks / worksheets and ELN that is detailed, timely and in compliance with GLP / GMP requirements.
Contributes data to the preparation of high-quality technical reports as source documents for regulatory submissions.
Reviews data for compliance and adherence to specifications and acceptance criteria.
Communicates results according to project timelines and works with collaborators to understand project needs and contribute to overall analytical control strategy. Draws basic conclusions from data and results.
Complies with Environmental Health and Safety Requirements
Skills / Knowledge Required:
Hands-on experience with separations techniques (HPLC, UPLC, GC, etc.) and instrumentation software.
Familiar with HPLC, dissolution, FT-IR, UV/VIS spectrophotometry, titrations, etc.
Experience in the development and performance of analytical tests for a variety of drug substances and products (including solid oral dosage forms and injectables) is a plus.
Expectations of an Associate Scientist Include:
Strong verbal and written communication skills, and interpersonal skills as a team player.
Willing to work in an environment where individual initiative, accountability to the team, and professional integrity are required. This position will have direct impact on department sub-team or project team performance.
Familiar with cGMP/GLP guidelines, ICH, FDA, and EMA guidelines.
Familiar with USP and other compendia.
Recognizes analytical test problems, can investigate problems and take appropriate steps to resolve and communicate issues. Recognizes technological limitations and addresses them usually under guidance of lab manager/direct supervisor.
Exhibits sound scientific judgment based on reasonable assumptions and available information.
Demonstrated ability to conduct and document analytical laboratory experiments under minimal supervision.
BS/MS Chemistry (or relevant discipline).
Minimum 3 years cGMP / GLP pharmaceutical laboratory experience