What are the responsibilities and job description for the QC Analyst position at Joulé?
Job Title: QC Analyst
Location: Novato, CA
Type: Contract
Compensation: $20 - $27.58 hourly
Contractor Work Model: Onsite
Hours: Sunday-Wednesday 7:00 am to 6:00 pm PST but may change due to business needs (Shifts are Sunday-Wednesday Day (7am to 6pm) /Swing (Midnight to 1pm) or Wednesday-Saturday Day (7am to 6pm) /Swing (Midnight to 1pm))
Overview
The Quality Control Analytical In-Process (QCA-IP) Analyst is responsible for performing 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 A280, Bradford, and UV Absorbance, Enzyme activity, HPLC/UPLC, and method validation.
Requirements:
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Ref: #558-Scientific
Location: Novato, CA
Type: Contract
Compensation: $20 - $27.58 hourly
Contractor Work Model: Onsite
Hours: Sunday-Wednesday 7:00 am to 6:00 pm PST but may change due to business needs (Shifts are Sunday-Wednesday Day (7am to 6pm) /Swing (Midnight to 1pm) or Wednesday-Saturday Day (7am to 6pm) /Swing (Midnight to 1pm))
Overview
The Quality Control Analytical In-Process (QCA-IP) Analyst is responsible for performing 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 A280, Bradford, and UV Absorbance, Enzyme activity, HPLC/UPLC, and method validation.
Requirements:
- 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.
- Demonstrated working knowledge with respect to certified functional activities.
- Good documentation, written and verbal communication skills are essential.
- Must possess the ability to perform most tasks with minimal supervision.
- Computer literacy is required, with proficiency in Microsoft Word and Excel, and experience in Microsoft PowerPoint preferred.
- Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements
- Timely facilitation of incoming sample receipt and accessioning flow, decipher batch assignments across all assay types in accordance with agreed upon best practices.
- Execute 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.
- 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.
- 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.
- Assist with monitoring and the control of laboratory supply and critical reagent inventories.
- Qualify as trainer for specified methods, provide training to less experienced staff.
- Exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures, perform initiation of investigation records within required timeframes.
- Provide input or assay support to the progression of test method validation, investigations, technical studies, and method transfer protocols.
- Attend team huddles and department meetings, generate ideas for laboratory infrastructure improvements and method optimization.
- Perform other responsibilities as deemed necessary.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Ref: #558-Scientific
Salary : $20 - $28