About the role
The Quality Control Reviewer, Sample Management Department, is responsible for the quality control review of documentation related to the Sample Management team. He/she also conducts audits within the team to ensure that quality standards are met. He/she participates in the drafting and/or revision of standard operating procedures for sample management and glass washing.
What you'll be doing here
- Perform 100% quality control on documentation generated by the sample management team.
- Responsible for quality within the sample management team.
- Perform audits within the team: develop, execute and write reports.
- Completes additional information forms as necessary to ensure documentation is accurate and complete.
- Complete documentation necessary to track deviations and non-conformance reports within the team.
- Respond to QA citations.
- Archive documentation.
- Write, revise and/or review standard operating procedures for sample management and glass washing.
- Write, revise and/or update training materials.
- Keep abreast of relevant regulatory developments in the industry.
- Perform all work in accordance with applicable SOPs, GCPs and GLPs and adhere to all company guidelines and policies.
- Keep abreast of new SOPs, procedures and techniques through training sessions, meetings and internal communications.
What you need to succeed
- You have a high school diploma or higher in health sciences or equivalent with at least 3 years' experience.
- You must have in-depth knowledge of FDA-GLP, GCP and TPD regulations.
- Experience in the medical or pharmaceutical field is an asset.
- Excellent management, organizational, communication (written and oral) and interpersonal skills.
- Strong GLP/GCP focus.
- Detail-oriented.
- Strong leadership, decision-making and problem-solving skills.
- Customer oriented.
- Must be bilingual (French and English).
- Software: Access, Outlook, MS-Office, Watson.
Altasciences strives to provide a French working environment for its employees in Quebec. Although as part of its francization program has taken all reasonable steps to avoid imposing the above-mentioned requirement. Fluency in English is an essential requirement for the position of QC Reviewer, Sample Management including, but not limited to, for the following reasons:
- The requirement to have study protocols, designs and clinical research documents written and documented in English as required by industry regulatory agencies.
What we offer
Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.
Altasciences' incentive programs include:
- Training and development programs
- Employee orientation bonus program
- Annual performance reviews
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