QC Scientist
2 months ago
About the Role
The Quality Control QC Scientist in our organization is responsible for generating leading quality control initiatives with minimal supervision, including second sourcing, developing test methods, and troubleshooting lab and product issues in accordance with the requirements for ISO, FDA QSR, and company policies.
Key Responsibilities
- Assist with developing test methodologies and procedures
- Assist and train laboratory technicians and specialists
- Work with quality specialists on internal and external audits and audit training
- Assist with developing and validating methods
- Support and develop chemical testing procedures
- Support and develop technical requirements for raw material specifications based on input from potential vendors, product development staff, and process engineering
- Coordinate failure investigations by designing and performing lab-scale simulations of products made in the plant
- Troubleshoot and calibrate laboratory equipment
- Maintain and order laboratory supplies
- Lead: Assist with directing the work of laboratory employees
- Lead: In the supervisor's absence, manage day-to-day operations, including scheduling, submitting requisitions to obtain laboratory supplies, and reviewing documentation
Requirements
- Bachelor's degree in a relevant technical field (chemistry, biology, or other relevant technical degree program)
- Minimum 6 years of relevant laboratory testing experience in a regulated industry (FDA/ISO 13485)
- Knowledge of standard quality tools, such as FMEA, Root Cause Analysis, and Statistics
- Ability to work in a fast-paced environment with strict deadlines
- Ability to make recommendations on improvements to test methods and procedures
- Ability to make decisions on experimental steps and data analysis within defined parameters and guidelines
- Ability to recognize and communicate unexpected experimental results to the supervisor, interpret data with minimal direction, participate in defining next steps with the supervisor, and retrieve information from scientific literature
About STERIS
STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. We help our customers create a healthier and safer world by providing innovative healthcare, life sciences, and dental products and services. STERIS is a $5 billion, publicly traded company with approximately 17,000 associates and customers in more than 100 countries.
STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred, and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state, or local law.