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Senior Quality Control Specialist
4 months ago
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
You Will Have The Opportunity To:
Assist in supervising and, as well as the QC activities to be performed during the conduct of studies
Assist in hiring activities, performance evaluations, and routine monitoring of productivity
Assist in staff knowledge development; organizes and conducts QC training as appropriate
Assist in ensuring efficiency and mobilization of the QC staff to achieve expected results
Assist in maintaining quality standards for QC and ensures adherence to study protocols, BPSI SOPs, Directives, and ICH-GCPs guidelines and regulatory requirements
Assist QC staff in addressing study-related issues while providing guidance and directions to QC staff
Analyze and develop action plans to address QC findings, including the development of CAPA reports
Ensure all study-related activities (especially Phase 1, HAL studies) are performed in compliance with Protocol, BPSI SOPs, and regulations
Ensure all prepared study source documents and/or forms (especially Phase 1, HAL studies) are in accordance to protocols, SOPs, and regulations
Ensure that all study-related documentation is reviewed to confirm the quality, reliability, accuracy, completeness and consistency in accordance with Protocols, SOPs, GCP guidelines, and applicable regulatory requirements, as well as, adhere to the established timelines
Review all other study-related documentation: medical screening files, pharmacy labels, and files
Ensure the conduct of clinical trial according to the applicable Good Clinical Practice (GCP) guidelines, applicable regulations, Protocol and BPSI SOPs at all times
Work closely with CRCs to ensure studies are conducted properly with high quality and high efficiency
Observe, on a random basis, clinical procedures during the conduct of studies, sample bundling, and shipping process
Provide reports of the reviewed data to relevant personnel/department
Develop and utilize QC Checklist or other QC tools designed to document the QC review process
Establishes and Performs training of new QC Staff
Provides input to the clinic calendar, assists Management with daily operations as required
Participate in the review of SOPs and Protocols
Performs other tasks and projects as assigned
What you will bring:
Completed Post-secondary degree in a science or healthcare related discipline, or equivalent work experience.
2+ years of relevant clinical research experience, knowledge of ICH-GCPs, and professional experience working in CRO
Ability to accommodate a flexible work schedule and to adapt to changing priorities; able to work under pressure.
Excellent attention to detail
Minimum Leadership skills
Certification in Clinical Research is an asset.
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