QC Analyst

Functional activities may include: performing a wide variety of analytical assays, maintaining test sample throughput, monitoring lab supplies, preparing reagents, contributing to process and method validation studies, supporting investigations and equipment validation, and brainstorming further development or improvement ideas for procedures. 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.

QC Analyst
Duration: 1 year contract+
Location: Novato, CA
Shift: Wednesday - Saturday Onsite 4 days, swing shift 1pm-11:30 pm
Pay: $30.00/hour - $32.50/hour

PURPOSE
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, UV Absorbance, Enzyme activity, HPLC/UPLC, and method validation.

CHARACTERISTICS
Functional activities may include: performing a wide variety of analytical assays, maintaining test sample throughput, monitoring lab supplies, preparing reagents, contributing to process and method validation studies, supporting investigations and equipment validation, and brainstorming 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 QCA-IP Job Profile Analyst 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.

RESPONSIBILITIES
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 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. 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.
4. 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.
5. Assist with monitoring and the control of laboratory supply and critical reagent
inventories.
6. Qualify as trainer for specified methods, provide training to less experienced staff.
7. Exhibit proactive communication upon occurrence of compliance risks and deviations
from laboratory procedures, perform initiation of investigation records within required
timeframes.
8. Provide input or assay support to the progression of test method validation,
investigations, technical studies, and method transfer protocols.
9. Attend team huddles and department meetings, generate ideas for laboratory
infrastructure improvements and method optimization.
10. Identify areas to improve operational excellence by reducing non-value-added activities
and increasing process efficiency.
11. Perform other responsibilities as deemed necessary.

QUALIFICATIONS
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.





Benefits (employee contribution):
Health insurance
Health savings account
Dental insurance
Vision insurance
Flexible spending accounts
Life insurance
Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.