Job Description

. The Company BioPharma Services Inc. is a subsidiary of Think Research. BioPharma Services was founded by two surgeons dedicated to advancing medical science to improve the life and spirit of their patients. With this same dedication and vision in mind, these physicians brought life to BioPharma. Through each success, and even some failures, the perpetual drive to make BioPharma great has been determined by the will and dedication of our people. The will to empower their colleagues, friends and teammates to excel in all facets of clinical research and inspire performance to achieve greatness. It is with this same culture and brand of excellence that we welcome our clients. To experience the team community that has propelled us into a global leader in medical research, to be a client-focused partner, where people and patients matter. Again, we invite you to come and meet our people. Our people who have learned that success is better achieved and celebrated as a team than as an individual. Why Us?

• It's not every day that you have the chance to change the way your friends and family are cared for - Make an impact!
• Everything we do – and we do it with passion – is to improve the quality of life for patients who benefit from the clinical trials that we perform for global pharmaceutical companies.
• We’re growing, and so will you with leaders who will support your development through mentorship and other opportunities

• Collaborative, creative, dynamic and flexible work environment, with a start-up spirit

The Role The primary responsibilities of the Quality Assurance Coordinator are to assist with distribution of companywide Standard Operating Procedures and manage QA documents. You Will Have The Opportunity To: The primary responsibilities of the Quality Assurance Coordinator are to:

• assist with distribution of companywide Standard Operating Procedures
• manage QA documents e.g. CAPA reports/Investigation reports/deviation reports
• assist with projects to improve efficiencies
• other duties to assist the Quality Assurance Department

The primary responsibilities of the Archiving Coordinator are to:

• storage and retrieval of study records and administrative documents
• ensure that access to the archive is controlled
• ensure that movement of records and materials in and out of the archives is properly controlled and documented
• receipt of study records to be archived
• indexing of records as per established procedures.
• archiving non-study specific records
• disposal of archived records and materials
• transfer to sponsors or third parties, if applicable
• provide training to back-up archivists and other archiving staff, as required

What You Will Bring:

• University degree in a scientific area, or equivalent experience.
• Working knowledge of OECD Principles of Good Laboratory Practice, ICH guidelines, GLP, FDA regulations and guidelines.
• Related experience in quality administration, preferably in quality system documents (polices, SOPs, forms, etc.) and archiving.
• Experience writing and reviewing Standard Operating Procedures (SOPs).
• Excellent coordination of activities, organization skills, multi-tasking, communication and interpersonal skills.

Think Research and all subsidiaries are proud to be an equal opportunity employer and is committed to creating a diverse and inclusive workplace, free of discrimination and harassment. We provide equal employment opportunities (EEO) to all employees and applicants regardless of race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We are committed to providing accommodations for people with disabilities. Should you require an accommodation, we would like to work with you to meet your needs.
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