À propos du poste
We are seeking a highly motivated Quality individual who is interested in joining our fast-paced, dynamic startup environment. The Compliance Specialist is responsible for activities related to Quality Management System (QMS) oversight, audit, and inspection follow up (CAPA) and will support readiness activities. Reporting to the Compliance Quality Manager, this individual works closely with Quality members and provides support in all continuous improvement activities. This position will work cross functionally on continuous improvement activities to drive effective, compliant, and sustainable solutions/ outcomes. Incumbent will proactively assist the business in the identification of potential risks and perform activities to ensure mitigation to improve 503B compliance and enhance performance of key 503B activities. Core to these activities will be the ability to effectively complete projects and foster effective interdepartmental and cross-functional partnerships.
• Assist in projects that impact the Quality
Management System. Report on progress
against schedules, milestones and project
goals, evaluate project resource needs and
availability, identify and report
gaps or project constraints, and develop
solutions for successful implementation.
• Evaluate compliance with QA processes,
Equipment Qualification, and Computer
principles. Support all regulatory and
customer quality audits.
• Gather, organize & analyze data to develop
solutions & alternative methods of
continuous improvement projects to optimize
operations to deliver process improvements
• Assist CAPA teams, and other project teams, in
the development of action plans and
schedules, and the verification of completed
• Identify compliance issues that require follow-
up or investigation.
• Conduct internal investigations of compliance
• Conduct internal investigations of customer
• Maintain documentation of compliance
activities, such as investigation outcomes.
• Track compliance issues within all
departments and ensure completion within
• Disseminate written policies and procedures
related to compliance activities.
• Discuss emerging compliance issues with
management or employees.
• Provide assistance in internal or external
• Prepare management reports regarding
compliance operations and progress.
• Monitor/Track compliance systems to ensure
their effectiveness. Oversee internal reporting
systems and inform employees about these
Knowledge and Experience:
• BS/BA degree with 2 years of pharmaceutical
industry experience in quality
or an equivalent combination of education and
experience in a scientific or health-rated field
• Minimum 2 years directly related experience
supporting compliance in a quality/compliance
/applicable compliance field.
• Knowledge of QMS and CAPA related tools or
systems is preferred.
• Environmental monitoring or audit experience
is an asset
• Experience with health authority inspections
and inspection readiness activities preferred.
• Strong personal leadership with demonstrated
competency interfacing with department lead
• Working knowledge of applicable US FDA, USP
and state board regulatory requirements and
guidelines as applicable to the pharmaceutical
• Excellent communication skills:
• Listening, interpreting and summarizing
• Clear and concise verbal communication
• Professional and concise written
communications –exceptional attention to
• Strong organizational skills, with the ability to
effectively prioritize and manage multiple
projects and tasks, with attention to detail.
• Strong interpersonal skills and the ability to
assist personnel in a matrix organization,
ability to proactively resolve issues in a
diplomatic, flexible, and constructive manner.
• Highly ethical, self-motivated and self-
directed; works effectively independently as
well as in a team environment.
• Strong project management skills: MS Word,
• Flexible and able to adapt to company growth and evolving responsibilities.
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.