Senior QC/QA Technician (Thursday-Sunday/9am-7pm)

Sirtex; Wilmington (MA); Hybrid; USD 59,000 - 75,000; Full time

Benefits offered by this job

Health insurance

401k matching

Paid time off

Job summary

Sirtex Medical in Wilmington, MA is seeking a Senior Quality Control/Assurance Technician to ensure products meet defined quality and regulatory standards in a clean room environment.

The role is onsite in Wilmington, MA with a Thursday–Sunday, 9:00 AM–7:00 PM schedule. Responsibilities include inspections, testing, material release, documentation, and training on Quality Systems.

Qualifications

• Minimum of a High school degree required.
• Fluent in English (read, write and speak).
• 3+ years’ experience handling chemicals and using basic laboratory equipment.
• 3+ years’ experience in a medical device, pharmaceutical, or other regulated industry required.
• Strong organizational and time management skills.

Responsibilities

• Ensure activities are performed in accordance with Quality System requirements, work instructions and regulatory requirements.
• Support manufacturing by performing duties such as incoming, in-process, final inspections, DHR completion, Quality Control testing, product release, etc.
• Authorize release of approved material, intermediates and finished product
• Prevent release of suspect or known nonconforming products and materials
• Perform microbiological testing of environment and products as necessary
• Adhere to clean room practices and gowning procedures
• Follow detailed process steps without deviation.
• Organize reports, files, and results in a professional proficient manner.
• Conduct training to Quality Systems processes as defined within the Sirtex LMS.
• Be flexible to work in a small team to ensure coverage.

Skills

Quality control

Regulatory compliance

Clean room

Lab testing

Education

High school diploma

Tools

Laboratory equipment

Job description

• Full-time
• Compensation: USD 59,000 - USD 75,000 - yearly

Company Description

Sirtex Medical is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated to improving patient outcomes.

Our mission is to be at the forefront of minimally invasive cancer and embolization therapies. By partnering with physicians, we aim to provide innovative products that enhance patient outcomes and simplify treatments. Achieving this ambitious goal requires passionate and talented individuals who are committed to making a difference. Our flagship product, SIR-Spheres® Y-90 resin microspheres, is a targeted radiation therapy for liver cancer. To date, we have delivered over >150K doses across 50+ countries, significantly impacting patients' lives worldwide. Our success is fueled by our dedication to serving the medical community, maintaining professionalism, fostering a collaborative work culture, nurturing an entrepreneurial spirit, and continuously pursuing innovation and improvement.

At Sirtex, we are committed to creating a great workplace. We offer a range of benefits, programs, and services to support our employees, ensuring they have opportunities to contribute to our success and advance their careers. Join our inclusive community, where you can collaborate with talented colleagues, bring your ideas to life, and advance your career, all while delivering innovative healthcare solutions to patients.

Job Description

Job Description

SCOPE:

The position of Senior Quality Control/Assurance 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 meeting the demands of production timelines and commitments.This position requires the successful candidate to be onsite in our Wilmington, MA facility.The scheduled shift for this position is Thursday-Sunday from 9:00 AM - 7:00 PM. All candidates must be willing to work this schedule weekly.This position is responsible for:

PRIMARY RESPONSIBILITIES:

• Ensure all activities are performed in accordance with Quality System requirements, work instructions and regulatory requirements.
• Support manufacturing by performing duties such as incoming, in-process, final inspections, DHR completion, Quality Control testing, product release, etc.
• Authorize release of approved material, intermediates and finished product
• Prevent release of suspect or known nonconforming products and materials
• Perform microbiological testing of environment and products as necessary
• Adhere to practices designed to protect both employees and product from contact and potential contamination, including suitable gowning and clean room practices
• Follow detailed process steps without deviation.
• Organize reports, files, and results in a professional proficient manner.
• Conduct training to Quality Systems processes as defined within the Sirtex learning management system.
• Be flexible and work within a small team without strictly defined roles to assure complete functional coverage

Qualifications

• Minimum of a High school degree required
• Fluent in English (read, write and speak)
• Ability to learn and successfully execute tasks such as visual inspection and testing utilizing basic laboratory equipment
• 3+ years’ experience handling chemicals and using basic chemical laboratory equipment.
• 3+ years’ experience working in a medical device, pharmaceutical, or other regulated industry required.
• Personable, energetic, responsive and confident
• Strong organization and time management skills
• Self-starter with the ability to learn and work as part of a team.
• Strong verbal, written, analytical, persuasive skills and ability to interact effectively with all levels
• Strong interpersonal skills, energetic, proactive, flexible with high integrity and ethics in all dealings
• Basic office computer skills (email, word processing, and spreadsheet software)

The target base salary range for this position will range from $59,000 to $75,000 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 Information

All 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.

• 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.

Diversity drives innovation; inclusion fosters belonging, growth and success. Sirtex believes that 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.