About the job
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 System Validation
principles. Support all regulatory and customer quality audits.
• Gather, organize & analyze data to develop solutions & alternative methods of proceeding; execute
continuous improvement projects to optimize operations to deliver process improvements
• Assist CAPA teams, and other project teams, in the development of action plans and implementation
schedules, and the verification of completed actions.
• Identify compliance issues that require follow-up or investigation.
• Conduct internal investigations of compliance issues.
• Conduct internal investigations of customer complaints.
• Maintain documentation of compliance activities, such as investigation outcomes.
• Track compliance issues within all departments and ensure completion within defined timelines.
• Disseminate written policies and procedures related to compliance activities.
• Discuss emerging compliance issues with management or employees.
• Provide assistance in internal or external compliance reviews.
• 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 systems.
Set yourself apart
Knowledge and Experience:
• BS/BA degree with 2 years of pharmaceutical industry experience in quality assurance/quality control
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 function
/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 is
• Working knowledge of applicable US FDA, USP and state board regulatory requirements and
guidelines as applicable to the pharmaceutical industry.
• Excellent communication skills:
• Listening, interpreting and summarizing information
• Clear and concise verbal communication
• Professional and concise written communications –exceptional attention to detail
• 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
• Strong project management skills: MS Word, Excel, PowerPoint,
• Flexible and able to adapt to company growth and evolving responsibilities.
What’s on offer?
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.