QARC Coordinator

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

• Your ideas influence the way we work, and your voice matters here.

• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

To provide administrative support to the Global QARC department and to the Manager, Process & Compliance.  Responsible for assisting in the tracking and maintenance of the CAPA database, SOP Change Request Log and SOP Deviation Log

What you will be doing: 

• Liaises…Provide core administrative support, organizational and day-to-day operational assistance to the Global QARC Department.

• Manage and maintain accurate and efficient (spreadsheets, databases and records) systems in respect of the Global QARC Department.

• Proactive approach to the ongoing development of enhancing the Department’s administrative and organizational procedures.

• Assist with the preparation, administration and organization of Audits performed by both Premier Research and Sponsors.

• Maintain all QARC databases, especially the CAPA database in relation to Inspections, Sponsor and Internal audits.

• To assist with travel itineraries and associated arrangements for QARC staff.

• Any other duties or ad hoc projects as required by Line Manager.

• Manage and maintain the SOP Deviation Log and the Change Request Log.

• Assist the Manager, Process & Compliance with the release of new and updated SOPs and provide support in collating signatures.

• Release of documents to external parties and management of access to restricted SOPs.

What we are searching for:  

• Relevant organizational and administrative experience

• Computer literate, with a working knowledge of the commercial programmed currently in use

• Excellent team player.

• Excellent English Communication Skills (interpersonal, written, verbal)

• Detail orientated and well organized

• Ability to adapt to changing priorities, take initiative and follow through on own

• Ability to multitask and work effectively in a fast-paced environment with changing priorities.

• Verbal and written communication skills.

• Excellent organizational and time-management skills, able prioritize work to meet deadlines.

• Accountable and dependable.

• Is customer service focused in approach to work both internally and externally.

• Maintains a positive, results orientated work environment.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status