Quality Management Systems Specialist

Om jobbet

Fagron has an exciting opening as a Quality Management Systems Specialist in our St. Paul facility. This position will have responsibility for a variety of Quality Management (QMS) Processes and Software: especially systems Equipment Preventive Maintenance, Corrective and Preventive Action (CAPA), internal and external audit, and various quality continuous improvement activities.

Duties & responsibilities:
•  Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
•  Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
•  Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
•  Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
•  Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
•  Coordinates legal requests in support of government investigations or litigations.
•  Ensures the quality assurance programs and policies are maintained and modified regularly.
•  Facilitates uniform standards for the site and enables best practice sharing, thereby fostering the achievement of company's mission globally.
•  Management and facilitation of quality documentation system.
•  Work within a GMP regulated manufacturing area to provide and assist in the implementation of quality-related continuous improvement opportunities.

Din profil

Job Requirements:

Must Have:
•  Bachelor's degree in a science or technical related field and 3+ years of work experience in Quality or regulated industry OR advanced degree with 1+ years of work experience in Quality or regulated industry
•  Experience with QMS and validated software
•  Document control system operations
•  GMP experience

Preferred:
•  Pharmaceutical industry experience
•  Experience with FDA, DEA, or other federal or state regulatory bodies
•  Working knowledge of 21CFR 210 & 211

Vi tilbyder

Fagron US offers its associates competitive compensation and a wide range of benefits including a 401(k) plan with a generous company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.