Senior Quality Specialist

Advanced Instruments, LLC; Westbrook (ME); On-site; USD 85,000 - 110,000; Full time

Job summary

Join Advanced Instruments, LLC as a Senior Quality Specialist, where you will play a pivotal role in ensuring product and process compliance with regulatory standards. This role involves collaborating with cross-functional teams, ensuring the effectiveness of quality systems, and leading initiatives to enhance quality standards in the biopharmaceutical and clinical testing industries.

Benefits

Flexible Medical, Dental, & Vision Coverage

Competitive 401k company match

Bonus Program

Generous PTO and paid holidays

Generous Tuition reimbursement

Professional development, engagement and events

Company marketplace for lunch and snacks

Qualifications

• 10+ years overall quality experience with a minimum of 5 years in quality systems.
• Extensive knowledge of ISO 17025, ISO17034, 21CFR Part 820, cGMP, ISO13485, and ISO 9001.
• Previous experience in a laboratory environment.

Responsibilities

• Ensure compliance with regulatory requirements, standards, and internal quality policies.
• Monitor processes for improvement and implement changes to enhance efficiency.
• Work with cross-functional teams to implement quality standards.

Skills

Organizational skills

Verbal communication

Written communication

Job description

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Innovate, Empower, Grow—With Advanced Instruments

For nearly 70 years, Advanced Instruments has been at the forefront of innovation, helping organizations enhance quality, achieve reliable outcomes, and boost productivity in the biopharmaceutical, clinical, and food & beverage industries. We don’t just develop cutting-edge technology—we empower our customers with solutions that drive efficiency, precision, and performance.

From Solentim, revolutionizing cell and gene therapy with advanced imaging and single-cell deposition, to OsmoTECH and OsmoPRO micro-osmometers, delivering accurate and reliable lab results worldwide, we set the standard for quality and reliability. Our Artel portfolio ensures precision in liquid handling through advanced validation, automation, and calibration tools. What sets us apart? With customer-centricity at our core, we take ownership, push boundaries, and collaborate to make a meaningful impact. Headquartered in Norwood, MA, with locations in UK and Westbrook, ME, our 340 employees worldwide are driving exciting growth this year.

Our Mission: To drive innovation that optimizes processes, increases efficiency, and delivers confidence in results.

Our Vision: To improve patient health through innovation and excellence.

If you're looking for a career where ingenuity, accountability, and collaboration fuel success, join us and be part of a team that’s shaping the future of our industry.

A Day In The Life

The Senior Quality Specialist will ensure products, services, and processes are in compliance with regulatory requirements, standards, and internal quality policies. They are responsible for ensuring traceability of measurements and by providing technical knowledge of products and processes throughout the organization.

What Are We Looking For In You

• Review product/manufacturing processes and test results to ensure procedures are complied with and external standards are followed
• Ensure regulatory requirements (ISO, cGMP, FDA, etc.) for the Calibration and Manufacturing laboratories
• Correlate knowledge and understanding of uncertainty of measurement to maintain analytical budgets and advise and adjust as necessary
• Monitor processes and identify areas for improvement, implementing changes to enhance efficiency and reduce defects
• Correlate knowledge and understanding of theory and technical elements of testing and calibration to write, execute and review product and process validations and verifications
• Work with cross-functional teams, including engineering, production, and quality control, to implement and maintain quality standards
• Extensive knowledge of ISO 17025, ISO17034, 21CFR Part 820, cGMP, ISO13485, and ISO 9001
• 10+ years of overall quality experience, with a minimum of 5 years quality systems experience
• Previous experience in a laboratory environment
• Strong organizational, written, and verbal communication skills
• Ability to work full time in office, 5 days weekl y
  
  

Work Location: Westbrook, Maine

What's in it for you?

• Flexible Medical, Dental, & Vision Coverage
• Competitive 401k company match
• Bonus Program, Generous PTO and paid holidays
• Generous Tuition reimbursement
• Professional development, engagement and events
• Company marketplace for lunch and snacks!
  
  

EEO Statement

Advanced Instruments takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Advanced Instruments will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Privacy policy

https://advancedinstruments.showpad.com/share/DmsEd5QTLlqemTYABlvDW

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

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