Quality Assurance Auditor
2 weeks ago
**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 Quality Assurance Auditor is responsible for planning, conducting, and reporting quality assurance audits as scheduled. The QA Auditor supports QA Management in promoting and assessing compliance of clinical and non-clinical studies with applicable regulations, guidelines, study protocols, study plans and company SOPs.
**You Will Have The Opportunity To**:
- Performs inspections of Bioanalytical GLP and Non-GLP studies, for compliance with the OECD Principles of Good Laboratory Practices, Study Plans and Standard Operating Procedures (SOPs) at the critical phases of the studies including Study Plans, In-process audits, Raw Data Audits and Analytical Report Audits and reports the observations of such inspections to the Principal Investigator(s) and Laboratory Management.
- Performs audits of Method Validation activities including in-process audits, raw data reviews and Validation Report.
- Conducts various facility, process and system audits, including audits of equipment maintenance, training records, archiving processes and computer validation and reports the observations of such inspections to the Laboratory Management.
- Performs audits of clinical trials for compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), study protocols, pertinent regulations and guidelines (FDA, Health Canada, EMA, etc.) including pre-study documentation, in-process activities, end-of-study documentation and clinical study reports.
- General Quality Assurance Statements for Analytical Reports, and Clinical Study Reports as per Standard Operating Procedures.
- Performs Vendor Qualification Audits.
- Keeps Management up to date with findings and follow up on corrective actions.
- Assists in the review, control and distribution of SOPs.
- Assists QA management in hosting sponsor and regulatory audits/inspections.
- Trains other QA staff on tasks/activities specified by QA management.
- Assists QA management in the training of BPSI staff on SOPs, GCP, GLP, etc.
- Coordinates and interacts with other departments to ensure corporate, departmental and project goals are met.
- Performs other relevant tasks delegated by QA management.
**What You Will Bring**:
- University degree in a scientific area, or equivalent.
- 1-2 years QA experience, preferably including audits of Phase 1 and /or BA/BE studies
- Excellent working knowledge of Principles of GLP, ICH guidelines, OECD, GCP, FDA regulations and guidelines, HPFB guidelines and Canadian Food and Drugs Act.
- Experience writing and reviewing Standard Operating Procedures (SOPs).
- Excellent hand-eye coordination, organization, 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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