Job DescriptionJob #: 1024094
A major biotech company is looking for a QC Analyst I in Novato, CA! If interested in the role, please send your most up-to-date resume to recruiter Austin Scrivner at firstname.lastname@example.org
Job Title: QC Analyst I
Location: Novato, CA
Shift: Sun-Thursday 8am-5pm
- The QC In-Process (QCIP) Analyst is responsible for performing microbiological and analytical test methods on in-process intermediates and varying stages of drug products, under minimal supervision and within cGMP guidelines, to support further manufacturing of commercial and clinical therapeutics.
- This role will involve knowledge that includes but is not limited to the following analyses and concepts: Protein determination by BCA, Bradford, and UV Absorbance, Enzyme activity, Endotoxin detection, Bioburden quantification, HPLC, Total Organic Carbon, microbial identification and challenge studies, aseptic techniques, and method validation.
- Candidate will be expected work Monday-Friday day shift for the first couple of weeks during training.
- Functional activities may include: performing a wide variety of microbiological and/or analytical assays, maintaining test sample throughput, monitoring lab supplies, preparing reagents, contributing to process and method validation studies, supporting investigations and equipment validation, and brainstorm further development or improvement ideas for procedures.
- Employee is expected to follow SOPs, make appropriate decisions in daily activities with minimal needs for intervention, and be able to recognize deviations from routine practices.
- Incumbent must accurately complete tasks on time to achieve lab goals, meanwhile limiting GMP / procedural errors, and be capable of accepting and incorporating feedback.
- Employee must be able to interpret results against defined criteria, begin to apply critical thinking to routine work.
- He/she should demonstrate an ability to evaluate results against trend reports, serve some degree of troubleshooting and capacity as trainer, and embrace an active role in following up on atypical results or issues.
- Communication of relevant information must be made to appropriate audiences, and attendance of necessary team meetings with some participation in discussions is essential.
- Employee should also be actively engaged in his/her role, exhibit frequent volunteerism as the work schedule flow permits, and maintain a positive attitude.
- Bachelor of Science degree.
- 0-3 years of relevant laboratory experience.
- QC specific experience is preferred.
- Experience with quality management systems, current Good Manufacturing Practices, and QC principles.
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