Job Details

Level
Experienced

Job Location
Phoenix, AZ - Phoenix, AZ

Remote Type
N/A

Position Type
Full Time

Education Level
Undisclosed

Salary Range
Undisclosed

Travel Percentage
Negligible

Job Shift
Undisclosed

Job Category
QA - Quality Control

Description

Position Summary:

The NC/CAPA Analyst primarily responsible with providing quality oversight and NC/CAPA support at Caris Life Sciences.

Job Responsibilities:

• The NC/CAPA Analyst is responsible for ensuring compliance and providing oversight of the NC and CAPA procedures.
• Review all NC/CAPA program deliverables with applicable functional groups.
• Assist the Manager - NC/CAPA with creating metrics to assess the NC and CAPA programs.
• Develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed.
• Analyzes reports and defective products to determine trends and recommend corrective actions. Collaborates with supplier representatives on quality problems
• Ensures that effective corrective actions are implemented and contributes to supplier quality improvement programs.
• Ensure compliance to CAPA processes and procedures. Support Quality Assurance Director with investigation/CAPA triage meetings (as necessary), including collaboration with customer groups as required.
• Responsible for review and approval of NCs and CAPAs for completeness, accuracy, effectivity, and timeliness along with the review and approval of CAPA changes and extension requests.
• Liaise with relevant functional groups, facilitate and mentor teams through all stages of the NC/CAPA process.
• Ensure users provide necessary rigor to the CAPA system content including maintenance of a live record with all relevant evidence attached in a timely manner.
• Facilitate and coach NC and CAPA teams in the application of problem-solving techniques and promote its uses and development (e.g. human error reduction, 4-D, etc.).
• Act as a subject matter expert on all related procedures, ensuring compliance to the relevant procedures.
• Ensure adequate training is maintained, and provided to all users of CAPA process and systems.
• Lead and participate in cross-site and corporate project teams in areas of CAPA and quality system improvement.

Required Qualifications:

• BS in a science, engineering or related discipline
• 3+ years of experience.
• Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening and reference verification. Also, individual must be fully vaccinated for COVID-19 by the date of hire to be considered for U.S.-based jobs, if not currently employed by Caris Life Sciences.

Preferred Qualifications:

• Preferred working knowledge and understanding of U.S. and International medical device regulations and supporting Quality Systems (audits, management review, quality planning, etc.).

Core Skills & Competencies:

• Must possess strong communication, project management and influencing skills and have the ability to manage multiple tasks simultaneously.
• Strong written and oral communication and negotiation skills.
• Ability to multi-task and work in a fast-past, deadline driven environment.
• Drive for Results (Service, Quality, and Continuous Improvement) - Ensure procedures and processes are in place that lead to delivery of quality results and continually reassess their effectiveness to achieve continuous improvement.
• Communication - Proficient verbal and written communication skills. Willingness to share and receive information and ideas from all levels of the organization in order to achieve the desired results.
• Teamwork - Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team.
• Customer Service Focus - Demonstrate a focus on listening to and understanding client/customer needs and then delighting the client/customer by exceeding service and quality expectations.

Physical Demands:

• Employee may be required to lift routine office supplies and use standard office equipment.
• Ability to sit for extended periods of time.
• Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes and bio-hazardous material in the lab environment.

Other:

• This position requires periodic travel and some evenings, weekends and/or Holidays.

This job description reflects management's assignment of essential functions. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

*Interested parties please email your resume to Tonia Hunter @ [email protected]. #LI-TH1