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QC Reviewer, Sample Management (12-month contract)
Job description
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 #LI-MB1
Description copied from Altasciences's careers page. Read the full posting before you apply.
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