Job Description

Employment Type: Full-time

Position Overview

Clario is a 50+ year old company that delivers industry-leading clinical trial endpoint technology solutions. We are seeking a Quality Assurance professional to manage quality events and CAPAs, addressing impacts to study conduct, data quality, and participant health and safety. This role is crucial in ensuring the integrity and quality of our clinical trial solutions as new technologies revolutionize the field.

What You'll Be Doing

• Serve as a key resource for the generation of quality metrics and process improvement for the Quality Unit.
• Assist with the implementation and maintenance of Quality Management Systems (QMS).
• Manage Corrective Action and Preventive Action (CAPA) responses received for internal and vendor audits, and responses defined for external audit observations.
• Conduct follow-up with applicable departments to ensure timelines for corrective actions are met.
• Assist with the development, generation, and distribution of KPIs and other key quality metrics.
• Create and document new flows, procedures, documents, training, and other support materials.
• Assist the Quality Unit with updates to Standard Work Instructions and Standard Operating Procedures.

Other Duties and Responsibilities

• Manage multiple QA tasks in parallel and effectively prioritize tasks to align with corporate quality objectives.
• Demonstrate effective time management, tracking deliverables, and escalating issues to supervision when necessary.

Requirements and Skills Needed

• Education: Bachelor's Degree, preferably in a Scientific or Technical Field.
• Experience:
  • 2 to 5 years of related experience within an FDA-regulated industry environment.
  • Prior experience in a Quality Assurance role.
  • Knowledge of GDP and GCP required.
  • Experience with Quality Management Systems and CAPA preferred.
  • Knowledge of 21 CFR Part 11, 21 CFR 820.20, ISO 9001/13485, and applicable regulatory authorities preferred.
• Skills:
  • Exceptional written and verbal communication skills.
  • Strong attention to detail.
  • Strong working knowledge of editing, proofreading, spelling, grammar, and punctuation.
  • Skilled at organizing information into a clear and concise written form.
  • Ability to work independently as well as in a team environment.
  • Proficient in Excel.

What We Offer

• Competitive compensation
• Private health insurance
• Engaging employee programs
• Flexible work schedules
• Attractive PTO plan
• Flex workspace

Company Information

Clario is a 50+ year old company that delivers industry-leading clinical trial endpoint technology solutions. The future of clinical trials is vibrant, with new technologies revolutionizing what’s possible. From new trial modes to faster and integrated evidence and findings, our innovative clinical trial solutions mean we can unlock better evidence.

EEO Statement

Clario is an equal opportunity employer. Clario evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.

Note: The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned as required. Clario reserves the right to amend or change this job description to meet the needs of Clario. This job description and any attachments do not constitute or represent a contract. The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above-listed qualifications.