The Quality Analyst I, Bioassay will be responsible for performing daily lab operations with the assigned functional area related to the release of product, and/or monitoring of the IMF environment, as well as complete other assigned duties.
Performs routine environmental monitoring, including air viable, particulate, viable surface sampling, and purified water system sampling/testing.
Performs assays for qualifying raw materials and for release or stability testing of in-process and finished products. These test methods may include flow cytometry, ELISA, endotoxin, complete blood count, viability, gram stain, growth promotion, and sterility.
Receives and maintains traceability and integrity of test samples, reagents and materials used in the laboratory per approved procedures.
Initiates and takes ownership as needed of laboratory investigations and exception reports for out-of-limit samples, and of other projects and related assignments.
Revises and updates standard operating procedures.
Performs testing in support of method validation studies.
Adheres to good documentation practices to ensure data integrity and traceability
Uses professional concepts and company policies and procedures to solve a variety of problems.
Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action.
Normally receives general instructions on routine work, detailed instructions on new assignments.
High School Diploma or Equivalent Required
Associate or Bachelor’s (preferred) degree in a scientific discipline or equivalent
Typically 2+ years related experience in cGMP/FDA regulated industry
Knowledge of basic lab testing techniques
Basic level of analysis skills required to evaluate and interpret data to arrive at logical conclusions
Attention to detail, quality and compliance with strict adherence to test procedures and protocols
Ability to learn new technologies and processes quickly and to understand the technical concepts behind each assay performed
Knowledge of cGMP/QSR/ICH and FDA device/drug/biologics regulations preferred.