QA Analyst responsible for validating software quality at Toon Boom, leading end - to - end testing and troubleshooting for high - performance applications.
About the role
- Quality Assurance Specialist at Grifols ensuring high quality standards and regulatory compliance for plasma products with international impact.
Responsibilities
- Receive, record and evaluate incoming "lookback" alerts.
- Maintain documentation for active and closed alerts.
- Ensure that all documentation from the donation center is legible and correct.
- Ensure that plasma units identified in a "lookback" alert and included in the internal inventory of Plasma Logistics Centers (PLC) are flagged for removal in the inventory management system.
- Ensure that all "lookback" alert notifications received are handled in accordance with applicable regulations and established Standard Operating Procedures (SOPs).
- Assist in the investigation and closure of customer complaints initiated at the logistics center (PLC).
- Investigate and report on in-process/finished products and processes that do not meet quality specifications, and document these deviations in a deviation report.
- Participate in drafting or reviewing policies and Standard Operating Procedures (SOPs) related to plasma processing and quality systems at the GPLC, including participation in the annual document review.
- Assist in the training of new quality assurance employees and in retraining existing employees when necessary.
- Be responsible for the quality release (QA release) of plasma originating from the PLC and verify that all shipment contents comply with SOPs, regulatory requirements, and customer requirements prior to release.
- Create the plasma lot certificate of conformity using GPOPQD and update SGP test methods.
- Review and verify center and transport temperature documentation to ensure compliance with the appropriate temperature specifications for lot release.
- Unlock units in SGP and complete the plasma conformity assessment.
- Assist the leadership team in research activities, such as reviewing audited donors and creating certificates of conformity to facilitate lot release.
- Perform and support investigations related to "lookback" alerts as well as audited donor assessments.
Requirements
- Bachelor’s degree in science minimum (preferably microbiology, chemistry, or biology) or equivalent professional experience;
- At least 3 years of experience in quality assurance within the biopharmaceutical or pharmaceutical manufacturing industry;
- Specialist-level expertise with advanced knowledge of quality systems (change control, deviations, investigations, root cause analysis, CAPA, and risk assessments);
- Demonstrated judgment, technical competence, and knowledge essential to the role;
- Good computer skills with MS Office and Adobe Acrobat;
- Strong organizational skills, including attention to detail and the ability to meet deadlines;
- Able to apply, follow, and rigorously maintain rules, regulatory requirements, procedures, and processes;
- Able to work independently and in a team;
- Able to multitask while collaborating to meet and exceed objectives;
- Lead initiatives to improve company practices, processes, and quality;
- Support and actively collaborate with colleagues;
- Facilitate cross-functional collaboration and manage assigned projects;
- Good oral and written communication skills and strong interpersonal abilities;
- Bilingual in French and English (English proficiency is required for document exchanges and communications with other Grifols sites outside Quebec and Canada, including Spain and the USA).
Benefits
- N/A
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