Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
Position Summary
Reporting to the Quality Assurance (QA) Manager (QMS), the Quality Specialist II ensures our site meets the GMP requirements and corporate policies. This role is key within our QA team, directing quality compliance initiatives, identifying areas for ongoing improvement, and meeting regulatory and client requirements precisely. Focusing on quality risk reduction strategies, you will support efforts to guarantee our site procedures align closely with cGMP and corporate guidelines.
This role is essential in upholding our quality management systems, overseeing product quality assessments, handling documentation, providing training, managing suppliers, and ensuring data integrity. You will also guide the site on the quality system and develop a multisite network to achieve excellent results.
Responsibilities
- Write and review relevant procedures and SOPs across various functional teams.
- Configure and maintain QMS systems to support GxP compliance, authoring related SOPs/Work Instructions.
- Coordinate site change control, assess changes affecting product quality, and ensure effective management.
- Maintain and develop actions for CAPA systems, ensuring timely completion and efficiency checks.
- Perform evaluations to confirm alignment with regulatory requirements.
- Manage document and record control, ensuring adherence to site requirements.
- Lead GMP training systems, develop training plans, and improve GMP training modules.
- Develop and complete annual product quality review plans, including trend analysis and necessary CAPAs.
- Conduct site self-inspection programs to ensure compliance with cGMP and corporate policies.
- Coordinate and complete inspection readiness activities for client and regulatory audits.
- Support site management review processes, collect and analyze quality data, and drive continuous improvement.
- Coordinate site supplier management programs, including Quality Agreements.
- Track all QMS events to ensure timely closure.
- Ensure site data accuracy and successful application throughout the site.
- Perform additional related duties as assigned by the company.
EHS
- Understand and implement emergency procedures and safe systems of work.
- Ensure adherence to environment, health, and safety rules, signage, and instructions.
- Promptly report and investigate all accidents, near misses, and rule breaches.
Minimum Requirements/Qualifications
Education:
- Bachelor’s Degree or equivalent experience in Life Sciences, Chemical/Biochemical Engineering, or a Pharma-related Scientific Area.
Experience:
- 2 - 4 years of relevant Quality experience in pharmaceuticals preferred.
- Experience with Quality Management Systems, particularly TrackWise, is an advantage.
- Experience in biologics and aseptic training is an asset.
- Experience in maintaining the accuracy and consistency of site data is an asset.
Proficiencies:
- Experience with cGMP and Regulatory Compliance along with GMP Quality Management Systems.
- Effective detailed thinking and interpersonal skills.
- Strong coordination and teamwork abilities.
- Focus on delivering effective outcomes.
- Proficiency in problem-solving and Quality Risk Management.