Perform method feasibility, method validation, and dose analysis on pharmaceutical products (including both hot (radioactive) and cold studies).
Perform method verification for compendia monographs using a wide array of instrumentation.
Draft reports using generated results.
Performs SPV (data review) of data generated by other analysts in the team.
Work independently on assigned projects and report progress and issues with study direction team and supervisor/manager.
Draft quality records such as quality events and investigations.
Understanding of laboratory waste streams and documentation of such activities, which is especially critical for maintaining safe radioactivity levels within laboratory.
High attention to detail.
Flexibility in schedule when working on studies based on formulation delivery. Note dates that clinical activities occur is typically scheduled well in advance.
HPLC experience is desired.
Additional Responsibilities Depending On Prior Experience
Drafting methods from client provided documents.
Client facing opportunities in regards to analytical method development.
Perform instrument qualification activities as needed.
Draft and modify SOPs for instrumentation and GMP processes as needed.
Draft quality records such as change controls.
Perform formulation development testing as needed.
Compensation for this role: $23-$26/hour
Seniority level
Entry level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Biotechnology Research
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