Senior Quality Control Associate
The Quality Control Senior Associate will be part of the Angiocrine QC team that supports all QC laboratory activities in support of release testing of a cell-based therapy undergoing clinical investigation. A successful candidate should have some experience in cell/gene-therapy product testing under GMP, including familiarity with aseptic technique, immunoassays, flow cytometry, and PCR. This is a full-time position and will report to the QC Supervisor.
Position Responsibilities and Requirements:
- 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
- Execute 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
- Perform GMP bioanalytical release testing for cell banks and/or finished cell-based drug products
- Perform GMP stability testing for materials, cell banks, and/or finished drug products
- Participate in out-of-specification (OOS) investigations and deviations
- Conduct peer review of data generated in QC lab
- Maintain inventory of laboratory consumables
- Assist in the validation of bioanalytical test methods
- Assist in the qualification of equipment/instruments
Some weekend work may be required depending on testing schedules.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Preferred Education and Experience
- Related Bachelor’s degree (e.g. biology, biotechnology, biochemistry)
- 3+ 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.
This position is based in San Diego, CA.
Angiocrine is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.