QC Analyst I, IND
GENERAL SUMMARY OF POSITION:
The Quality Control Analyst I - IND is responsible for analysis of clinical samples using ELISA and cell-based assays, and for analysis of formulated drug product (vaccine or monoclonal antibody) according to standard operating procedures. The Quality Control Analyst I is also responsible for assisting with in vitro and in vivo assay development to support research projects. Compiles data for documentation of test procedures and prepares reports. May conduct microbial and endotoxin testing on environmental, in-process, bulk and final vial samples. Applies knowledge of good manufacturing practices and good laboratory practices on a daily basis. The position requires occasional weekend work.Responsibilities
- Perform assays in the QC Laboratory as set forth in SOPs, adhering to cGMP and cGLP regulations.
- Performs ELISA and cell-based assays set forth in SOPs.
- Assists in the development of in vitro and in vivo testing methods to support research projects.
- Conducts microbial and endotoxin testing on environmental, in-process, bulk and final vial samples as required.
- Collect and process water and other samples as necessary.
- Performs preliminary review and sign-off of assays.
- Performs cell culture to maintain cell lines.
- Prepares and tests reagents used in assays as needed.
- Assists in the qualification of new controls, standards and reagents.
- Generates, maintains and trends assay parameter data for designated assays.
- Troubleshoots assay problems with supervisor.
- Participates-in writing, reviewing and revising SOPs and reports.
- Maintains log books related to inventory and equipment.
- Ensures labs are clean and safe (in compliance with cGMP), and properly stocked.
- Performs other additional job-related duties as required.
- Bachelors degree in a scientific discipline or equivalent with a minimum of 0 to 2 years relevant experience.
- Ability to follow instructions precisely, recognize deviations, and recommend corrective action within scope of training
- Ability to adapt to a cGxP regulated environment
- Ability to troubleshoot within scope of training
- Computer literate and proficient in MS Word, Excel and other relevant electronic systems.
- Strong time management and organizational skills. Demonstrated ability to multitask and consistently meet deadlines
- Ability to apply [scientific and / or other applicable principles to problem solving
- Possesses well developed attention to detail, ability to maintain accurate records and excellent proofreading skills
- Excellent written and verbal communication skills. Ability to communicate effectively with others
- Demonstrated initiative through past experience
- Ability to work effectively both independently and as a member of a team