What are the responsibilities and job description for the Engr 1, Quality position at Katalyst CRO?
Company Description
Roles & Responsibilities:
All your information will be kept confidential according to EEO guidelines.
- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Roles & Responsibilities:
- Quality Engineering is responsible for product and service quality evaluation and control.
- Works cross-functionally in the development and or maintenance of products or services.
- The Engineer is involved in resolving the equipment and process-related production issues, activities including equipment, process, materials, /and method validation as well as statistical analysis and metrics to analyze those systems and processes being measured.
- Demonstrates basic knowledge of quality engineering policies, principles and best practices.
- Demonstrates basic knowledge of FDA/ISO requirements.
- Applies basic statistical sample size calculations to work for quality determination on simple projects.
- Applies basic understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with direct supervision.
- Writes test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intended.
- Has basic knowledge of theories, practices and procedures in a job family or skill Applies knowledge and skills to complete own work Depends on others for instruction, guidance and direction.
- Develops competence in own area by performing routine work.
All your information will be kept confidential according to EEO guidelines.
