Within this role you will perform a wide variety of bioanalytical processes to support bulk drug substance manufacture in a cGMP regulatory environment.
As a QC Analyst within the Bioassay Lab, a typical day might include, but is not limited to, the following:
1. Ensuring that all work carried out is in compliance with current GMP, the required regulatory standards, conforming to company policies and standard operating procedures (SOPs)
2. Reviewing data from other analysts for accuracy and completeness
3. Performing bioassays in compliance with cGMP practices
4. Sub-culturing mammalian cell lines and performing cell counts
5. Maintaining laboratory reagents and supplies
6. Preparing reagent aliquots and media for use in cell-based assays
7. Maintaining equipment in the laboratory
8. Conducting laboratory investigations and generating reports in response to invalid assays, deviations, OOS/OOT
9. Initiating and completing CAPAs in accordance with site procedures
10. Writing new and updating current SOPs as needed
11. Presenting bioanalytical data reports clearly and concisely to management
12. Identifying and implementing lab process improvements and lean initiatives
13. Performing any other duties relevant to the QC laboratory position as required
This role might be for you if:
1. You have current or prior experience working with Bioassays in a regulated environment
2. You have a proven ability to work independently or as part of a team
3. You possess strong trouble-shooting and problem solving skills
4. You have strong attention to detail & excellent written and oral skills
To be considered for this opportunity you must hold a BS/BA in Life Sciences or related field or an equivalent combination of education and experience with 2+ years experience working in a regulated testing environment. Previous experience working in a regulated Biotech environment is a distinct advantage.
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