AIM OF THE POSITION

The Senior QA/RA Specialist I is responsible for supporting the Senior Director of QA/RA in leading the planning, maintenance and improvement of compliance with Quality Management Systems (QMS) processes relevant to Agendia, Inc., which helps ensure compliance with regulatory requirements and standards that are applicable, such as FDA, CAP, CLIA, ISO). The Senior QA/RA Specialist I also ensures timely registrations and renewals, certifications, creation and maintenance of Technical Files, participates in design and risk management activities, and completion of other quality and regulatory work required to maintain worldwide compliance.

POSITION WITHIN THE ORGANIZATION

1. Reports to Senior Director QA/RA

2. Cooperates with all departments within Agendia.

3. Organizes activities within the QA/RA Department.

4. Participates in or leads:

- QA/RA meetings

- Project meetings

- Working groups

- Project groups

- Inspections / External Audits

- Supplier Audits

- Internal Audits

ESSENTIAL DUTIES AND RESPONSIBILITIES

o Maintains and improves the Agendia QMS [compliance with FDA, IVDR, CLIA, ISO, etc.].

o Ensures applicable standards and regulations pertinent to Agendia are effectively implemented and acts as an advisor to all managers.

o Leads development of regulatory submissions.

o Provides support to currently marketed products as necessary: labeling, product changes/documentation.

o Coordinates initiatives to support quality systems, IVDR and continuous improvement efforts.

o Collaborates with management team in development, and execution of goals, objectives and projects.

o Leads document control, including adherence to Good Documentation Practices and storage of records, for compliance related documentation.

o Manages the Quality System training program by sending notifications of training required and training records.

o Reviews batch records and other QMS documentation as needed.

o Manages at least one of the following processes with minimal supervision:

* Complaint Handling - investigation, escalation and reporting requirements as needed.

* Corrective and Preventive Action (CAPA) - tracking, trending of approved CAPAs, and driving timely/appropriate completion of activities.

* Deviations - tracking, trending, and driving timely/appropriate closure.

* Nonconformances - tracking, trending, and timely/appropriate closure.

* Internal Audits - conducting internal audits and/or serving as a Subject Matter Expert (SME); monitoring the progress of any required actions and their effectiveness in improving quality.

* Supplier Management - as needed.

* External Audits - as needed.

* Training - as needed on Quality and/or Regulatory topics.

o Leads obtaining and/or renewing of domestic and international certifications and registrations.

o Creates and maintains Technical Files.

o Facilitates design and risk management activities.

o Reviews regulatory affairs documents and compiles documentation for regulatory agencies and Notified Body.

o Develops and maintains a variety of metrics pertaining to QMS activities as assigned, including collecting/presenting data for Management Review and Quality Management Program reviews.

o Facilitates meetings related to QMS and Regulatory activities.

o Leads change orders/process improvements with respect to QMS procedures with direction from management.

o Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.

o Develops, supports and promotes company-wide compliance programs.

o Mentors, trains and coaches new personnel as required.

o Performs other related duties as required or assigned.

The above listing represents the general duties considered essential functions of the job and is not to be considered a detailed description of all the work requirements that may be inherent in the position.

KEY CONTACTS

Internal

o All levels of the organization and works especially close with the laboratory operations and department directors in R&D, Product Support, Clinical, Marketing, and IT. This position has interactions with all departments company wide.

External

o Vendors and regulatory agencies, such as the FDA, ISO Notified Bodies other global regulatory agents.

o Experience with State Clinical Boards and/or the College of American Pathologists (CAP), is preferred.

EDUCATION AND EXPERIENCE REQUIREMENTS

EDUCATION

o Bachelor's Degree in Molecular Biology or related field.

EXPERIENCE

o In vitro diagnostic or molecular reagent quality assurance, document control, configuration management, supply chain, operations, and/or quality departments within a regulated environment, preferred.

o Minimum of 5 years of industry experience; in vitro diagnostic or molecular reagent quality assurance or regulatory affairs preferred.

KNOWLEDGE, SKILLS AND ABILITIES (KSA'S)

o Advanced understanding and applying quality system regulations and standards, including GDP, CLIA, CAP, ISO 13485 and/or 21 CFR Part 820.

o Excellent critical thinking, problem solving and analytical skills.

o Effective interpersonal and communication skills and capable of supporting cross-functional project goals.

o Advanced experience in MS Word, Excel, and PowerPoint required.

o Advanced experience with delivering training material to groups.

o Must be team oriented and have effective communication skills to work as part of a team.

o Advanced experience in supporting and guiding ISO/FDA inspections is strongly preferred.

o Proven experience with official (external) training in auditing and in CAPA's (Corrective and Preventive Actions) preferred.

o Molecular biology or diagnostics experience preferred.

o ASQ Certification in CBA or CQA desired.

o RAPS Certification desired.

BEHAVIOURAL COMPETENCIES/DESIRED SKILLS

o Able to prioritize and plan work activities, use time efficiently and develop realistic action plans with detailed follow through.

o Ability to stay on task with little supervision.

o Willing to make decisions, exhibit sound and accurate judgment, and make timely decisions for the result with limited direction.

o Ability to learn and comprehend new technical skills and knowledge.

o Must have the ability to work as a team player within all levels of the company.

o Ability to effectively communicate with individuals and groups across interdisciplinary roles.

o Ability to read and interpret documents.

o Attention to detail.

o Proficient with MS Office, including Word, Excel and PowerPoint programs.

o Takes initiative.

o Flexibility.

o Can do-attitude.

* PRIVACY NOTICE: To review the California privacy notice, click here:

WORKING ENVIRONMENT

Establishes ADA (Americans with Disabilities Act) requirements

ENVIRONMENT/SAFETY/WORK CONDITIONS

Working conditions (inside or outside the office).

o General office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

o Regularly walks, stands, and sits.

o Regularly works on a computer for approximately 6-8 hours a day.

o Must be able to read and understand complex directions.

TRAVEL

o <10% Travel

OTHER DUTIES

Other duties as required.