Quality Assurance Associate

at  AGADA Biosciences Inc

OVERVIEW

AGADA is a contract research organization (CRO) providing specialized services to pharmaceutical and biotech companies. Unlike most CROs, AGADA provides services in niche areas of research that require further standardization. Our mission is to facilitate and accelerate drug development for rare diseases, serving an international clientele. Key to accomplishing this mission is training and retaining a highly skilled workforce in Nova Scotia. We offer both preclinical drug efficacy studies in mouse models and clinical (human) trial drug development and support services. AGADA has performed over 100 drug efficacy studies in mouse models of muscular dystrophy, has supported over 50 Phase I, Phase II/III clinical studies (Duchenne, Becker, ALS).
Our research team and our business have grown substantially and we need to expand our QA team. This QA position does not require substantial experience in QA, but we are looking for someone who has a keen interest in working alongside the research team to help build and maintain our quality system. AGADA is a non-GLP lab, but our procedures are GLP-like. We are GCP compliant, and, given our work with clinical trials, AGADA is often audited by client companies and is subject to audits from regulatory agencies (FDA, Health Canada, EMA).
The Quality Assurance Associate works with the Quality Assurance (QA) team to achieve Quality Assurance by complying with and ensuring fellow personnel’s compliance with the company’s SOPs and safety regulations.

PREFERRED SKILLS

• Excellent interpersonal, verbal, and written communication skills.
• Motivation to learn about industry-specific requirements and research.
• Demonstrated ability to be proactive, highly organized, and capable of multi-tasking, along with qualities to handle a fast-paced environment and ongoing change typical of the biotech industry.
• The ability to assess activities and suggestions that are aligned with the company’s needs and priorities.
• The ability to receive, reflect and think critically about client and staff feedback with regard to the QA program.
• Great attention to detail, the ability to successfully troubleshoot issues, and provide excellent support to the rest of AGADA staff.

QUALIFICATIONS AND EDUCATION

• A bachelor’s degree: in science would be an asset.
• Other education or industry experience relating to Quality Assurance, Life Sciences or Research is an asset

• Participates in regulatory, client, or visitor inspections.
• Ensures availability of staff to answer questions.
• Supports AGADA’s QA team.
• Takes notes.
• Helps to oversee the internal auditing process and communicate results.
• Standard Operating Procedure (SOP) Management.
• Ensures availability of SOPs to staff.
• Ensures SOPs are regularly maintained and updated.
• Performs form validations.
• Maintains records of quality reports and documentation.
• Updates management and staff on Quality Assurance changes or updates.
• Reviews study presentations and reports.
• Participates in trial-focused Quality Control (QC) meetings.
• Acts as a delegate to other QA members and the training team.
• Supports laboratory equipment validation and calibration.
• Works with the training manager on the development of training plans
• Manages or participates in weekly general laboratory meetings and staff discussions.
• Manages or participates in temperature and humidity monitoring system.
• Manages or participates in water quality testing.
• Participates in system improvements.
• Participates in vendor assessments.
• Participates in computer system validations.
• Participates in control change.
• Participates in consulting with the I.T. team.
• Participates in policy creation.
• Participates in inventory management.