9 часов назад
Manufacturing & QC Associate II (Molecular Biology)
68 000 - 85 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manufacturing & QC Associate II (Molecular Biology): Manufacturing diagnostic assay reagents and performing quality control testing for transplant-focused molecular diagnostics with an accent on cGMP documentation, real-time PCR, NGS, and laboratory automation. Focus on troubleshooting equipment and process issues, conducting validation and non-conformance investigations, and implementing CAPA and continuous improvements.
Location: Onsite in Brisbane, California
Salary: $68,000–$85,000 USD annually, with potential additional bonuses, incentives, and restricted stock units.
Company
develops and commercializes precision medicine, genomics-based testing, and digital healthcare solutions for organ transplant patients and caregivers.
What you will do
- Manufacture reagents for diagnostic assays and support development, verification, and validation activities.
- Perform quality control testing, data analysis, and documentation review to confirm reagent integrity and specification compliance.
- Maintain batch records, equipment logs, inventory records, and system monitoring reports in accordance with cGMP standards.
- Support equipment calibration, preventive maintenance, troubleshooting, root cause analysis, and process improvements.
- Participate in non-conformance investigations, disposition decisions, CAPA implementation, change management, and deviation resolution.
- Support validation protocol development, execution, reporting, document revisions, and onboarding of new personnel.
Requirements
- Bachelor’s degree in biological sciences, life sciences, or a related field, plus at least two years of relevant experience in manufacturing, clinical, or industrial laboratory settings.
- Hands-on laboratory experience and the ability to work independently from SOPs after appropriate training.
- Working knowledge of molecular biology and proficiency with laboratory automation and instrumentation, including setup, operation, and troubleshooting.
- Ability to manage multiple priorities, communicate effectively, collaborate across departments, and work independently with minimal supervision.
- Proficiency with Microsoft Office Suite and Adobe Acrobat; familiarity with LIMS, databases, and statistical or data analysis tools is desirable.
- Ability to work onsite in Brisbane, California and comply with safety, environmental, health, contamination-control, and regulatory requirements.
Nice to have
- Experience with high-throughput real-time PCR, Next Generation Sequencing, cGMP manufacturing, and molecular biology process development.
- Experience with Operational Excellence and Continuous Improvement methodologies.
Culture & Benefits
- Work in a mission-driven environment focused on improving outcomes for organ transplant patients.
- US employee benefits include health and welfare coverage, gym reimbursement, 401(k) matching, an Employee Stock Purchase Plan, and pre-tax commuter benefits.
- Full-time employees may receive up to 30 days of paid annual leave under the Living Donor Employee Recovery Policy.
- The role may occasionally require travel and includes physical activity such as standing, walking, operating equipment, and lifting or moving up to 20 pounds.
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