Quality Assurance Specialist

3 weeks ago

Winnipeg, Canada Prometic Plasma Res Inc Full time

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? We are a global healthcare company working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

**Quality Assurance Specialist**

**Summary**:
The Quality Assurance (QA) Specialist supports the QA department in providing quality oversight to ensure that center operations are conducted in compliance with established quality systems and regulatory requirements which in turn ensure product quality and donor safety. plasma operationssupport quality operations and work with a number of Quality Systems ensuring compliance is maintained to meet the current Regulatory requirements. The QA Specialist is responsible for product quality by evaluating various processes against validated methods and licensed parameters, while ensuring timely product release. Will interface with multiple departments to ensure successful results. The position will support regulatory reporting and communications as required. Other responsibilities will include individual and group projects to support Quality Assurance initiatives across the company.

**Primary Job Responsibilities**:

- Perform routine review of donor record files, production, and equipment records
- Identify, investigate and report, issues identified under the deviation management system
- Work with plasma operations to develop meaningful corrective and preventive actions, identify areas where deviation reoccurrence could be avoided, perform follow up for effectiveness
- Investigate and report on customer complaints. Interface with various departments to investigate and ensure timely resolution of complaints.
- Prepare quality reports, coordinate and manage investigations relating to trend analysis or problem areas
- Perform test result review, lookback, and consignee notifications
- Perform and report on inspection of manufacturing areas and ensure closure of findings.
- Assist in the delivery of GMP and Quality System training of center staff
- Review and monitor supplies to ensure critical supplies meet operational requirements and verify final disposition of unsuitable supplies.
- Perform document control functions, assist in review and revision of operating procedures
- Participate in regulatory and internal inspections/audits

**General Responsibilities and Job Requirements**:

- Bachelor of Science is required.
- Comprehensive knowledge and understanding of cGMPs, Health Canada or FDA regulations, and industry guidelines is preferred.
- Strict adherence to procedures and practices according to applicable regulations.
- Experience in conducting investigations is preferred.
- Excellent verbal and written communication skills in the English language.
- Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis; proactive with strong attention to detail
- Self-starter with robust work ethic and the ability to exercise good judgment.
- Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
- Ability to work independently with effective interpersonal skills for collaboration in a team environment.
- Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint)

We are an equal opportunity employer

EEO Minorities/Females/Disability/Veterans

**Location**:NORTH AMERICA : Canada : MB-Winnipeg**:CAWINNIP - Winnipeg**

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