Staff Quality Compliance Specialist
About The Position
Ensure departmental records, QMS procedures, and controlled documents comply with applicable regulations and standards. Ensure QMS processes, procedures, and quality documentation to maintain a state of audit readiness. Apply critical analytical thinking in the investigations and nonconformance systems specifically during root cause analysis, risk assessment evaluation, and corrective and preventive actions determination to guarantee that (potential and actual) nonconformances are properly addressed. Support other functions in resolving quality systems issues and concerns. Support internal, and third-party audits, regulatory inspection preparation and execution. Assist in closing audit findings by providing quality guidance for investigations, and implementation of resulting corrections, and/or corrective actions/preventative actions. Ensure responses are complete, defensible, and supported by objective evidence and timelines. Provide constructive feedback and guidance to elevate the organization's overall regulatory writing capability. Ability to distill complex information into clear, regulator-ready language Ability to manage multiple complex documents under aggressive regulatory timelines Typically requires a Bachelor's degree and a minimum of 8-12 years of related experience. At this level a graduate degree may be desirable with 4 years of related experience Flex Workplace: Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Requirements
- Bachelor's degree
- 8-12 years of related experience
Nice To Haves
- graduate degree with 4 years of related experience
Responsibilities
- Ensure departmental records, QMS procedures, and controlled documents comply with applicable regulations and standards.
- Ensure QMS processes, procedures, and quality documentation to maintain a state of audit readiness.
- Apply critical analytical thinking in the investigations and nonconformance systems specifically during root cause analysis, risk assessment evaluation, and corrective and preventive actions determination to guarantee that (potential and actual) nonconformances are properly addressed.
- Support other functions in resolving quality systems issues and concerns.
- Support internal, and third-party audits, regulatory inspection preparation and execution.
- Assist in closing audit findings by providing quality guidance for investigations, and implementation of resulting corrections, and/or corrective actions/preventative actions.
- Ensure responses are complete, defensible, and supported by objective evidence and timelines.
- Provide constructive feedback and guidance to elevate the organization's overall regulatory writing capability.
- Ability to distill complex information into clear, regulator-ready language
- Ability to manage multiple complex documents under aggressive regulatory timelines
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
