-
ID
#43843843 -
Job type
Permanent -
Salary
TBD -
Source
Apex Systems -
Date
2022-07-04 -
Deadline
2022-09-02
Quality Control Supervisor
California, San diego, 92101 San diego USAPermanent
Vacancy expired!
- Working with cells and products of animal or human origin
- Working with replication-incompetent retrovirus
- Working with chemicals or potential hazard
- Knowledge of current good manufacturing practices (cGMP) as they apply to Quality Control
- Supervise daily activities to maintain QC laboratory in a GMP-compliant state, including
- Keeping current on required training documents
- Following standard operating procedures (SOPs), protocols, and other instructions from management
- Ensuring that equipment/instrument maintenance, calibration, and cleaning is properly documented
- Ensuring segregation of GMP-related materials and test samples
- Performing release testing for incoming raw materials
- Maintaining cleanliness and organization of laboratory environment
- Oversee GMP bioanalytical release testing for cell banks and/or finished cell-based drug products
- Oversee GMP stability testing for materials, cell banks, and/or finished drug products
- Conduct out-of-specification (OOS) investigations and deviations
- Conduct peer review of data generated in QC lab
- Oversee inventory of laboratory consumables
- Oversee the validation of bioanalytical test methods
- Oversee the qualification of equipment/instruments
- Oversee data trending and other quality metrics
- Manage QC personnel against performance objectives
- Related Bachelor's degree (e.g. biology, biotechnology, biochemistry)
- 5+ years work-related experience in cGMP QC laboratory setting
- Working familiarity with software such as Microsoft Word, Excel, and PowerPoint
- Working experience with adherent cells
- Bioanalytical skills with hands-on knowledge/experience in immunoassay/ELISA, flow cytometry, PCR, and/or other bio-analytical techniques.
- Effective and clear written and verbal communication
- Ability to work in a high paced team environment.
Vacancy expired!
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