What are the responsibilities and job description for the QC Associate - II position at MWIDM Inc.?
Description
We are seeking a highly motivated individual to join us as a QC Associate, Quality Control. Reporting to the Manager, Quality Control in Oceanside, CA you will be a hands-on resource for QC Analytical. Initially as part of the start-up activities, you will be responsible for performing assay for the validation activities and getting trained on all the Analytical Assays. As the site transitions into operation, you will primarily be responsible for assay execution for analytical testing utilizing flow cytometry, ELISA, PCR, and cell-based bioassay. You’ll also contribute to the initiation and completion of quality records and SOPs associated with analytical testing at the site.
Additional Responsibilities (include but are not limited to):
- Support for assay performance of analytical issues in the context of a GMP laboratory.
- Represent QC for analytical methods in collaboration with Manufacturing and Analytical Development organizations.
- Author and revise processes and procedures for analytical method and associated work streams.
- Training and maintaining QC equipment in collaboration with method subject matter experts
- Coordinate with stakeholders for validation activities in alignment with established timelines
- Responsibility for ensuring electronic data meets Part 11 requirements in alignment with internal procedures
- Support deviations, investigations, CAPAs and change control activities as needed
- Participate in teams for lean improvement activities
- Support regulatory filings and response to questions
- Support inspection readiness activities
- Participate in generating training module and instruction led training material
- Other duties as required
Basic Qualifications:
- Master’s degree with 1 year of experience in cell Immunotherapy.
- Bachelor’s Degree and 3 years’ experience in the cell immunotherapy
- 6 years of relevant experience and a High school diploma.
Preferred Qualifications:
- Experience with Labvantage LIMS and other quality systems.
- Strong working knowledge of cGMPs.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
Job Types: Full-time, Contract
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Experience:
- Performing assay for the validation activities: 1 year (Required)
- Flow cytometry: 1 year (Required)
- ELISA: 1 year (Required)
- PCR: 1 year (Required)
- Cell-based bioassay: 1 year (Required)
Work Location: One location
