Marin Metro Area, CA
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.
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.
Work assignments will vary by degree of complexity. 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. Must also demonstrate the ability to both manage time and prioritize routine work effectively.
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.
1. Bachelor of Science degree.
2. 0-3 years of relevant laboratory experience; QC specific experience is preferred.
3. Experience with quality management systems, current Good Manufacturing Practices, and QC principles.