Analyst, QC I
46 Galli Road Novato, CA 94949 US
The Quality Control Process Monitoring (QCPM) Analyst is responsible for performing environmental monitoring and microbiological/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: Environmental monitoring, Water testing, 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, perform environmental monitoring sampling and testing of facilities, equipment, and utilities, 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. He/she must be willing to work second shift, overtime, weekends, and holidays as required.
1.Timely facilitation of incoming sample receipt and accessioning flow, decipher batch assignments across all assay types in accordance with agreed upon best practices.
2.Execute microbiological and/or analytical methods to facilitate in-process testing under applicable cGMP guidelines, as well as contribute to the prompt reporting of results to meet the required timetables of internal customers.
3.Perform environmental monitoring sampling and testing of facilities, equipment, and utilities.
4.Evaluate completed assay validity, calculate and summarize results, analyze data per expected or specification ranges. Assist with the compilation and verification of trend analysis reports.
5.Perform and collaborate with co-workers to appropriately share general housekeeping activity assignments, and ensure systems for laboratory maintenance are adequate for creating a consistent state of inspection readiness.
6.Assist with monitoring and the control of laboratory supply and critical reagent inventories.
7.Perform growth promotion of media and microbial identification testing.
8.Qualify as trainer for specified methods, provide training to less experienced staff.
9.Provide on call coverage to support oversight of QC laboratory equipment functionality.
10.Exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures, perform initiation of investigation records within required timeframes.
11.Provide input or assay support to the progression of test method validation, investigations, technical studies, and method transfer protocols.
12.Attend team huddles and department meetings, generate ideas for laboratory infrastructure improvements and method optimization.
13.Perform other responsibilities as deemed necessary.
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.
4.Demonstrated working knowledge with respect to certified functional activities.
5.Good documentation, written and verbal communication skills are essential.
6.Must possess the ability to perform most tasks with minimal supervision.
7.Computer literacy is required, proficiency with Microsoft Word and Excel is essential, experience with Microsoft PowerPoint, Access, or Visio is desired.
8.Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements.