Reporting to the Senior Manager, Quality, Pharmaceutical Distribution, the Quality Site Specialist (QSS) will be responsible for ensuring a product or service meets established quality standards, including reliability, usability, and performance.
At this level, the Quality Site Specialist typically:
- Works under limited direction with work evaluated upon completion to ensure objectives are met.
- Determines and develops approaches to solutions.
- Has frequent interorganizational and outside customer contacts.
- Represents the department on projects and may perform project leadership roles.
- Serves as the main quality point of contact at the DC level, representing the department.
- Provides resolutions to complex problems using judgment within policies and practices.
Section A – Specific Responsibilities
- Execute equipment qualification and mapping.
- Manage the temperature monitoring system.
- Draft quality assurance policies and procedures.
- Interpret and implement quality assurance standards.
- Evaluate the adequacy of quality assurance standards.
- Review the implementation and efficiency of quality and inspection systems.
- Plan, conduct, and monitor testing and inspection of materials and products to ensure quality.
- Document internal audits and other quality assurance activities.
- Investigate customer complaints and non-conformance issues.
- Collect and compile statistical quality data.
- Analyze data to identify areas for improvement in the quality system.
- Develop, recommend, and monitor corrective and preventive actions.
- Prepare reports to communicate outcomes of quality activities.
- Coordinate and support on-site audits conducted by external providers.
- Evaluate audit findings and implement corrective actions.
- Ensure ongoing compliance with quality and regulatory requirements.
Section B – General Responsibilities
- Promote understanding of quality standards and processes with Distribution Directors in the DC.
- Identify training needs and organize training interventions to meet quality standards.
- Ensure proper preparation, execution, and follow-up of regulatory inspections by maintaining inspection files, managing audit documents, and response actions.
Section C – Key Requirements
- B.Sc. in Chemistry, Biology, or equivalent experience.
- Experience in quality inspection, auditing, and testing.
- Experience in equipment qualification or mapping.
- Experience with corrective action programs.
- Product or industry-specific experience
- Strong computer skills, including Microsoft Office, QA applications, and databases.
- Knowledge of QA tools, concepts, and methodologies.
- Knowledge of relevant regulatory requirements.
- 4+ years of relevant experience.
- Strong leadership qualities in a professional environment.
- Ability to manage time and prioritize tasks.
- Excellent verbal and written communication skills.
- Data collection, management, and analysis skills.
- Problem analysis and solving abilities.
- Planning and organizational skills.
- Good judgment and decision-making capabilities.
- Ability to motivate teamwork.
- Capacity to work under limited direction.
LI-JT2
We offer a competitive compensation package as part of our Total Rewards, determined by performance, experience, skills, and other factors. Benefits details are available upon request.