Quality Analyst

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.

What we offer:

* Competitive compensation

* Private health insurance

* Engaging employee programs

* Flexible work schedules

* Attractive PTO plan

* Flex workspace

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 responses received for internal and vendor audits, and responses defined for external audit observations. Conduct follow-up with the 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 documentation of new flows, procedures, documents, training, and other support materials.

• Responsible for assisting Quality Unit with updates to Standard Work Instructions and Standard Operating Procedures.

OTHER DUTIES AND RESPONSIBILITIES:

• Manages multiple QA tasks in parallel and effectively prioritizes tasks to align with corporate quality objectives.

• Effective time management, tracking deliverables and when necessary, escalations to supervisor.

QUALIFICATIONS AND SKILLS NEEDED:

• Exceptional written and verbal communication skills, 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 look for:

Education:

• Bachelor's Degree, preferably in a Scientific or Technical Field

Experience:

• Knowledge of 21CFR Part 11, 21 CFR 820.20, ISO 9001/13485 and applicable regulatory authorities preferred.

• Must have 2 to 5 years of related experience, within a FDA regulated industry environment.

• Must have prior experience in a Quality Assurance role. Knowledge of GDP and GCP required.

• Experience with Quality Management Systems, and CAPA preferred.

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.

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.