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Laboratory Quality Control Specialist
2 months ago
Company Overview:
Quantimetrix is a reputable family-owned enterprise dedicated to the design, development, and manufacturing of clinical laboratory quality controls. With nearly five decades of experience, we pride ourselves on delivering exceptional products and services to the healthcare sector.
Position Summary:
We are seeking a qualified individual to become a part of our Research and Development team. The R&D Associate will play a crucial role in supporting the development of new laboratory quality control products and managing the lifecycle of existing products post-launch. This role requires a self-motivated individual capable of working independently with minimal oversight.
Contract Duration:
This position is offered as a contract for over six months, with the possibility of transitioning to a permanent role.
Key Responsibilities:
- Conduct feasibility studies, design characterization, and verification and validation testing for new product development.
- Plan, source, and oversee materials necessary for research activities.
- Draft and prepare test protocols and comprehensive reports.
- Analyze data and summarize findings effectively.
- Assist in the transition of new products to the manufacturing phase.
- Provide technical assistance for regulatory submissions and re-registrations following product launches.
- Support post-launch activities, including complaint investigations, corrective actions, and product enhancements.
- Maintain laboratory instruments and equipment, contributing to routine laboratory upkeep.
- Undertake additional tasks as assigned.
Qualifications:
- A minimum of two years of experience in a medical device environment, with knowledge of design control and cGMP preferred.
- Proficient in drafting technical documentation.
- Strong technical and analytical capabilities.
- Detail-oriented with proven troubleshooting and problem-solving skills.
- Excellent writing and communication abilities.
- Familiarity with Microsoft Word, Excel, and PowerPoint.
Educational Background:
Bachelor's degree in biochemistry, chemistry, clinical chemistry, or a related discipline.
Salary Information:
The compensation for this role ranges from $25 to $35 per hour, with variations based on experience, skills, education, certifications, and location.
