Quality Specialist Iii
2 weeks ago
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Position Summary**:
**Responsibilities**:
- Author and review relevant procedures and SOPs across functional teams.
- Prioritize safety as a fundamental goal throughout the organization.
- Configure and maintain QMS systems (e.g., TrackWise, eDMS, SFLMS) to support GxP compliance, authoring SOPs and Work Instructions.
- Coordinate the site change control system, ensuring all changes with potential product quality impacts are thoroughly evaluated and controlled.
- Manage the site CAPA system, crafting efficient actions, ensuring timely completion, and coordinating effectiveness checks.
- Conduct site-level corporate standards gap assessments to ensure compliance with regulatory requirements.
- Manage document and record management systems, overseeing effective execution and compliance with site requirements.
- Lead the development and execution of GMP training systems, creating training modules and annual plans.
- Develop annual product quality review plans, perform reviews, and implement CAPAs.
- Complete the site self-inspection program by developing annual plans, conducting inspections, and performing trend analysis.
- Ensure site readiness for client and regulatory audits, participating in hosting and managing responses to audit findings.
- Support the site management review process, collecting and analyzing quality data, and driving continuous improvement.
- Coordinate the site supplier management program, managing Quality Agreements, supplier change control, and participating in supplier evaluations.
- Lead and support Practical Process Improvement (PPI) activities related to QMS projects.
- Maintain the site data integrity system, ensuring efficient processes are in place.
- Perform and complete other related duties as assigned by the company.
**Education**:
- Bachelor’s Degree or equivalent experience in Life Sciences, Chemical/Biochemical Engineering, or a related scientific area.
**Experience**:
- 5-8 years of relevant quality experience in the pharmaceutical industry preferred.
- Experience with Quality Management Systems, specifically TrackWise.
- Experience in biologics and aseptic training is an asset.
- Strict experience in site data integrity management is essential.
**Proficiencies**:
- Practical knowledge of cGMP and regulatory compliance.
- Strong critical thinking and effective communication.
- Proven coordination and teamwork skills.
- Ability to lead executions and achieve results.
- Excellent problem-solving skills with a focus on continuous improvement and quality risk management.
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