QC Reviewer, Sample Management (12-month contract)
- Laval, QC, Canada
Full-time
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Job details
- Job type
- Full-time
- Apply by
- Experience
- You have a high school diploma or higher in health sciences or equivalent with at least 3 years' experience.
- Posting language
- English
- Posted
Original 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
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
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.
- 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.
- The requirement to have study protocols, designs and clinical research documents written and documented in English as required by industry regulatory agencies.
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
More about this job
Responsibilities
Review all documentation produced by the Sample Management team, conduct and report on team audits, and manage documentation related to deviations, non-conformances, QA citations, and archiving. Draft, revise, and review SOPs and training materials, while ensuring work complies with applicable regulations and company procedures.
Requirements
Requires a high school diploma or higher in health sciences or an equivalent qualification, with at least three years of experience and in-depth knowledge of FDA-GLP, GCP, and TPD regulations. Candidates must be bilingual in French and English and demonstrate strong organizational, communication, leadership, decision-making, and problem-solving skills; medical or pharmaceutical experience is an asset.
Skills
- Quality Control
- Documentation Review
- Auditing
- FDA-GLP Regulations
- GCP
- TPD Regulations
- Standard Operating Procedures
- Deviation Tracking
- Non-Conformance Reporting
- Training Materials Development
- Regulatory Compliance
- Attention To Detail
- Organizational Skills
- Written And Oral Communication
- Problem-Solving
- Leadership
Benefits
- Training And Development Programs
- Annual Performance Reviews
Visa sponsorship
Not detected in the job text
Categories
- Healthcare
- Science & Research
- Management & Leadership
Keywords
- Sample Management
- Quality Control
- Documentation Review
- Audits
- FDA-GLP
- GCP
- TPD Regulations
- Standard Operating Procedures
- Glass Washing
- Deviation Tracking
- Non-Conformance Reports
- QA Citations
- Document Archiving
- Training Materials
- Regulatory Compliance
- Health Sciences
- Medical Field
- Pharmaceutical Field
- Access
- Outlook
- MS Office
- Watson