Description:
Under general direction, perform testing and other activities in functions supporting the Quality Control department (QC Bio-assay).
- Perform Bio-Analytical testing such as Flow, ELISA, cell count, cell viability, residual bead assessment.
- Follows quality policies.
- Work on shifts covering daytime / evening and one or both weekend days.
- Execute method qualification/optimization of methods as per appropriate protocols.
- Contribute to OOS/OOE investigations and deviation investigations.
- Identify potential improvements in project work.
- Interface with regulatory agencies during audits.
- Contribute to assigned projects.
- Knowledge of LabWare LIMS and/or other QC data systems.
- Maintain GMP/GLP quality systems.
- Revise SOPs and forms.
- Monthly review of laboratory logbooks and monthly laboratory cleaning.
- Performing daily equipment startup and PQ
- Assure stock of reagents and materials In addition to these primary duties, provide coverage for all appropriate areas.
- Performs other job duties as assigned.
- 0 - 5 years of experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry.
- Knowledge of cGMP and an understanding of the concepts of GLP, good clinical practices and FDA guidelines, applicable state and foreign regulations, and standards routinely used in the industry (i.e. ANSI, ISO, etc.).
- Knowledge of bioassay test methods (Cell counts, Elisa, Flow cytometry).
- Knowledge of LIMS systems.
- Ability to communicate clearly with a variety of individuals in various aspects of company operations.
- Detail-oriented with expertise in problem solving and solid decision making abilities.
- Strong interpersonal skills which include a professional demeanor when interacting with company personnel.
- Sound, practical and appropriate regulations with regards to company
BA or MS in biology, chemistry, biochemistry, microbiology or other related science.