The Quality Assurance (QA) Associate II is a key member of the Quality Assurance Organization. The QA Associate performs Quality Assurance activities with minimal if any supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases. The ideal candidate will also support various Quality Management System needs.
- Ensures the accurate and safe release of various synthetic biology products in accordance with company and/or client procedures and requirements.
- Ensure and promote compliance with applicable ISO, cGMP, IVD Regulations, and company and client SOPs.
- Author and review relevant SOPs, validation and other documents.
- Responsible for the completion of all client requirements related to cellular product and/or material releases.
- Master Batch Record Control, distribution and label verification.
- Perform line clearance actives as required
- Materials management nonconformance disposition and release activity as applicable.
- Responsible for accurate deviation reporting as applicable and tracking/trending follow up actions to closures
- Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions
- Track and trend relevant quality metrics including environmental monitoring and calibration data
- Provide Quality Assurance related support to various departments.
- Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies.
- Effectively influences and trains employees (as required).
- Maintains strong communication network with peers.
- Demonstrated effective knowledge and use of various computer systems.
- Additional responsibilities as assigned
- Ability to travel 10%
- Bachelor's degree (or equivalent) in a scientific / engineering related field with 1-3 years of experience in the medical device/pharmaceutical/biotech industry
- Minimum 2 years of Quality Assurance or Regulatory Compliance (e.g. GCP, cGMP, GLP) experience
- Experience working and/or supporting production/laboratories a plus.
- Familiarity with regulatory requirements for IVD Products, ISO 9001, ISO 13485, 21CFR820, MDD, applicable experience in medical device, or biotech manufacturing and a thorough knowledge and understanding of cGMP.
- Familiarity with Confluence and JIRA applications desired.
- Strong written and verbal communication skills.
- Analytical and problem-solving skills
- Proven ability to work cross-functionally to achieve business outcomes.
About Twist Bioscience
Twist Bioscience synthesizes genes from scratch, known as “writing” DNA. Just as children learn to both read and write, the next phase of development for the genomics revolution is the ability to write DNA.
At Twist Bioscience, we work in service of people who are changing the world for the better. In fields such as health care, agriculture, industrial chemicals and data storage, our unique silicon-based DNA Synthesis Platform provides precision at a scale that is otherwise unavailable to our customers.
Twist Bioscience Corporation is an Equal Opportunity Employer. Twist Bioscience Corporation provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic characteristics, or any other category protected by law.