- Support Wilmington manufacturing by performing duties such as incoming, in-process and final inspections, DHR completion, product release, etc.
- Authorize release of approved material, subassemblies and finished product.
- Prevent release of suspect or known nonconforming product and materials.
- Perform microbiological testing of environment and product.
- Work with beta-emitting radioactive material in a safe manner, adhering to provided guidelines and safeguards.
- Ensure all activities are performed in accordance with Quality System requirements, work instructions and regulatory requirements.
- Follow detailed process steps without deviation.
- Organize reports, files, and results in a professional proficient manner.
- Adhere to practices designed to protect both employees and product from contact and potential contamination, including suitable gowning and clean room practices.
- Be flexible and work within a small team in order to assure complete functional coverage.
- Complete training to Quality Systems processes as defined within the Sirtex learning management system.
- High school degree
- Fluent in English (read, write and speak)
- Ability to learn and successfully execute tasks such as visual inspection and product testing.
- Previous experience working in Quality Assurance in a medical device, pharmaceutical, or other regulated industry preferred, but not required.
- Previous experience handling chemicals and using basic chemical laboratory equipment preferred, but not required.
- Strong organization and time management skills.
- Self-starter and the ability to work as part of a team.
- Strong verbal, written, analytical, and persuasive skills and ability to interact effectively with all levels.
- Basic office computer skills (email, word processing, and spreadsheet software).
- Undergo all formal Training Events as may be directed from time-to-time.
- Observe and comply with all Sirtex Corporate Policies.
- Work within, and ensure adherence to Quality System procedures, work instructions and other Quality System requirements.
- Work within, and ensure adherence to Health, Safety and Environment Management System procedures, instructions and other requirements.
- Diverse and flexible work arrangements to achieve the optimum balance between work and personal responsibilities.
- A culture of respect, diversity, collaboration, and innovation fostering inclusiveness and superior performance.
- Attractive compensation and benefit packages which are practical, robust and equitable.
- A commitment to support ongoing professional growth through career development, on the job experiences and training opportunities.
- Challenging work which supports the development of new and better ways to improve clinical outcomes for oncology treatment around the world.
- An unwavering commitment to company values, employee safety and excellence in everything we do.
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Quality Assurance Technician - Wilmington, United States - Sirtex
Description
Job Description
Job DescriptionCompany DescriptionSirtex Medical is a global healthcare business with offices in Boston, Sydney, Germany, and Singapore, working to improve outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients with liver cancer at more than 1,300 medical centers in over 50 countries.
At Sirtex, we're transforming our industry through our leadership with interventional oncology and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. We offer stimulating careers and development, encourage innovation, and strive for excellence in everything we do. We will always foster a diverse and inclusive workplace, in which our global teams are united by an unwavering commitment to improve the quality and longevity of patients' lives by providing innovative interventional oncology solutions.
Here, you will be a vital contributor to our inspiring and bold mission.
Job DescriptionSCOPE:
The Wilmington plant is one of the global sites for Sirtex, and for production of SIR-Spheres microspheres for various markets. The position of QA Technician is vital in assuring that only product meeting defined quality and regulatory standards leaves the manufacturing location. This position requires a detail oriented individual capable of working independently in a clean room environment and with the demands of production timelines and commitments. This role reports to the Quality Assurance Manager. This position has a schedule of Saturday through Wednesday, 8:00am-4:30pm.
PRIMARY RESPONSIBILITIES:
EDUCATIONAL PREREQUISITES AND SKILL REQUIREMENTS:
TRAINING REQUIREMENTS:
The target base salary range for this position will range from $64,000 to $77,000 annually. Individual compensation for this job requisition will be based on non-discriminatory factors, including your geographic location, skills, experience, education and other factors as they relate to the position requirements. Actual compensation may vary depending on the confirmed job-related skills and experience.
In addition to the expected base compensation, this role is eligible to participate in Sirtex's incentive programs (target bonus of 5% for this position) and benefit plans, which include paid sick and vacation time, health insurance and a generous 401k matching program.
Additional InformationAll your information will be kept confidential according to EEO guidelines.
Do you want to be part of something bigger? A team whose impact stretches across the globe making a real difference to the quality of people's lives. Sirtex recognizes that well-being, financial health, and work-life balance are crucial for our employees to achieve personal success.
Sirtex offers qualified candidates:
Diversity drives innovation; inclusion fosters belonging, growth and success. Sirtex believes that it takes multiple perspectives and voices to create a culture and workplace which fosters engagement, teamwork, and employee satisfaction to perform our best and deliver on commitments. We are dedicated to fostering an environment where all employees feel valued, included, and can share their ideas so that we can exceed even our own expectations.
Sirtex is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age or any other characteristic protected under applicable law. Sirtex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
