Capa Lead Jobs

Experience managing and improving Quality Management Systems and metrics

Experience with Quality Management Systems (Veeva, TrackWise, Veeva Quality Docs, etc.)

Perform other support responsibilities as requested to support Quality and Compliance activities.

Proven ability to manage multiple projects while maintaining quality

Strong interpersonal skills with reputation for collaboration with colleagues

Strong computer skills including MS Office (Word, Excel, PowerPoint, MS Project)

Able to apply strategic and quality logic and project management skills to investigation activities ensuring appropriate investigations are conducted.

Good project management skills to deliver an effective service in a timely manner.

Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, Medical Benefits start day 1

Ensures all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.

Bachelor's Degree preferably in Microbiology or Science field with 2 years CAPA work experience in manufacturing plant environment.

Minimum 2 years’ experience in regulated, manufacturing environment.

Must be a team collaborator, have exceptional organizational and time management skills, and be proficient with applicable software systems.

This is a remote position that be worked from home anywhere in the United States or Europe***

Lead the overall administration, tracking and management of Noncompliances and CAPAs at Advanced Clinical

Provide support to Compliance and Quality Management and Operations Quality teams

Provide training on the Noncompliance, CAPA and effectiveness check process/requirements to company staff

Certification: Has or will obtain within one year of hire at least one relevant certification (CQA, RQAP, RAC, etc.)

Demonstrates commitment to the development, implementation and effectiveness of ARDx Quality Management System per ISO, FDA, and other regulatory agencies.

Provide ongoing support to Quality management during external audits.

Manage the archival and handling of scanned CAPA records.

Critical Review of documents. Experience in assessing the weight of evidence associated with a claim/hypothesis/assertion is preferred.

Provide site administration of the CAPA program and support process owners in completing CAPAs and related business items.

Support and guide the Corrective Action Review Board and Users regarding the CAPA process, CAPA record content, and CAPA software.

Demonstrates commitment to the development, implementation, and effectiveness of ARDx Quality Management System per ISO, FDA, and other regulatory agencies.

Provide ongoing support to Quality management during external audits.

Excellent organization skills must be able to manage a large number of simultaneous projects

Manage the archival and handling of scanned CAPA records.

Critical Review of documents. Experience in assessing the weight of evidence associated with a claim/hypothesis/assertion is preferred.

Bachelor's degree, or the equivalent 1-2 years' experience in a FDA-controlled environment.

Communicate confidently and effectively with all levels of management, peers and key stakeholders, including timely escalation of quality issues.

Collaborate with cross-functional teams using various methodologies (e.g. Six Sigma root cause analysis/problem solving skills).

Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Minimum 2 years significant engineering and/or technical operational experience plus demonstrated competence.

Previous CAPA and/or quality assurance/engineering experience and demonstrated use of quality tools/methodologies.

Prior medical device experience preferred.

Strong Project Management skills, including ability to project manage all CAPA activities.

Montana employees are currently excluded from this requirement at this time.

Bachelor’s degree in an Engineering or Science related field or equivalent technical experience.

At least 3 years of experience in Medical Device or regulated industry.

Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations.

Demonstrated ability to partner with the business and effectively interact with and influence employees, and managers on all levels.