Education & Qualifications:
Education: Bachelor’s Degree or Technical Diploma in relevant field.
Experience: 5+ years’ experience in quality assurance and/or regulatory in the biotech industry or equivalent.
Specialized knowledge: Knowledge of regulatory requirements (e.g., ISO 13485:2003, CE medical and IVD device directives, cGMP, etc.) is required.
Knowledge, Skills and Abilities (KSAs):
- Proven ability to coordinate and execute responsibilities relating to Quality Assurance.
- Excellent communication skills.
- Good interpersonal skills.
- Highly organized and detail oriented.
- Willingness to learn and assume new responsibilities.
- Ability to handle multiple tasks in a fast paced environment.
- Aptitude for learning and working with various electronic/technology platforms.
- Self-motivated and independent work ethic.
- Ability to question and not always be satisfied with the status quo.
Duties & Responsibilities:
- Assist in maintaining the corporate-wide Quality Management System (QMS) required for the manufacture and distribution of STEMCELL products which include RUO and regulated products.
- Review of Certificates of Analyses, Batch Records and other related product documentation required for product release.
- Apply good documentation practices to all document review.
- Perform ERP transactions related to product release.
- Co-ordinate Quality interactions with Suppliers and ongoing Supplier monitoring to ensure accuracy of documentation and efficiency of product release.
- Collaborate with internal teams to represent compliance requirements related to document review and product release.
- Apply critical thinking to continuously improve product release processes.
- Edit and write Standard Operating Procedures.
- Support the Quality team in day to day activities.