2 дня назад
Analyst I, QC Environmental Monitoring (MedTech)
68 000 - 93 500$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Analyst I, QC Environmental Monitoring (MedTech): Conducting environmental monitoring and laboratory testing for cleanrooms, compressed gas systems, water systems, and medical devices with an accent on GMP compliance, data integrity, and regulated manufacturing controls. Focus on maintaining monitoring systems, completing chemical and physical analyses, supporting NCRs and CAPAs, and ensuring laboratory readiness for FDA and cGMP requirements.
Location: Hayward, California, United States. Applicants must be authorized to work for any employer in the U.S.; visa sponsorship is not available. Weekend work may be required to meet production schedules.
Salary: $68,000–$93,500 annually, plus potential discretionary bonuses.
Company
develops and manufactures healthcare and medical device products focused on saving and sustaining lives.
What you will do
- Conduct routine environmental monitoring of ISO 5, 7, 8, and 9 cleanrooms, compressed gas systems, and water systems.
- Perform chemical and physical testing of medical devices from incoming raw materials through finished goods.
- Enter QC data in SampleManager/BaxLIMS and complete routine, special-project, and protocol testing on schedule.
- Maintain and calibrate laboratory equipment and support audits and SOP updates.
- Support NCRs, CAPAs, and LIRs while coordinating updates with other departments.
- Maintain the environmental monitoring area in a GMP state and contribute to production, quality, efficiency, and problem-solving initiatives.
Requirements
- Bachelor’s degree in life sciences and experience in medical devices, pharmaceuticals, or another regulated industry preferred.
- Knowledge of laboratory assays, equipment, applicable procedures, EHS requirements, FDA regulations, CGMP, and GDP principles.
- Proficiency with laboratory equipment and tools, Microsoft Office, and computer systems.
- Strong organization, multitasking, planning, problem-solving, communication, and attention-to-detail skills.
- Ability to learn new computer systems and programs promptly and work effectively with internal and external partners.
Culture & Benefits
- Collaborative work culture centered on accountability, ownership, trust, and continuous improvement.
- Medical and dental coverage beginning on day one, plus life, disability, and travel accident insurance.
- 401(k) retirement savings plan with employee contributions and company matching, employee stock purchase plan, and flexible spending accounts.
- Paid holidays, 20–35 days of paid time off based on service length, family and medical leave, and paid parental leave.
- Educational assistance, commuting benefits, childcare benefits, employee discounts, and employee assistance programs.
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