Overview
This position is located in Rochester, NY.
Shift details: Monday–Friday, 40 hrs/wk, 2-week rotations between A shift (7:00 AM–3:30 PM) and B shift (1:30 PM–10:00 PM).
Qualifications
- A BA/BS Degree or equivalent is required.
- A degree in a science concentration is preferred.
- 1-2 years of experience.
- Previous laboratory or similar experience is required.
- Willingness to learn to operate, maintain, and troubleshoot Vitros 350, FS 5, 1, 3400, and 4600 analyzers.
- Analytical knowledge required for production releases.
- Experience in QO LIMS or SAP is preferred.
- Careful attention to detail and accuracy of work are required. As an FDA-regulated facility, documentation is key to meet regulatory requirements; understanding of cGMPs and documentation in a regulated industry is required.
- Experience in documentation protocols and procedures is a plus.
- Proven ability to plan and organize daily workload, strong teamwork, and demonstrated problem solving using innovative solutions.
- Working knowledge of computers and Windows software is desired.
- Full understanding of quality control is expected.
- Ability to multi-task, adapt to changing daily workload and priorities, and operate in a cross-functional team setting.
- Ability to work in a BSL-2 lab environment, which includes standing for long periods, wearing PPE, and handling human samples.
Responsibilities
- Support manufacturing operations in the laboratory by executing release testing and data analysis for product release.
- Operate, maintain, and troubleshoot Vitros testing equipment (Vitros 350, FS 5, 1, 4600, and 3400XT).
- Collaborate with Manufacturing Operations, Product Support, and other technical groups to ensure quality and customer expectations are met prior to final product release.
- Execute Vitros testing following designated Test Designs and analyze data for product release.
- Interact with data management systems such as LIMS, SAP, Windchill (Document Management System), and Non-Conformance & CAPAs (QERTS).
Company Description: Real Soft Inc. (RSI) is a US-based global software solutions company established in 1991, focused on delivering professional services and business solutions. Address: 125 Village Blvd, Forrestal Village, Suite 200, Princeton, NJ 08540.