Quality Assurance Specialist 4

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Function of Position

As a member of the Fluorescence Imaging, LLC organization, the QA Specialist 4 is directly accountable for ensuring investigational drug product is manufactured, tested, and dispositioned in compliance to meet Intuitive FI’s timelines for clinical use and program development. Reporting to the Director, Quality Affairs, the team member is expected to unsupervised work on complex problems related to compliance with GMPs for drug development activities. This requires investigation of situations or data, in-depth evaluation of various factors and leveraging GMP guidelines and regulations. This position exercises compliance judgment within broadly defined practices and policies while autonomously guiding the best way forward in obtaining results that are compliance and help the business goals.

The team member assures safe and efficacious imaging products, through effective quality oversight of CMO site activities. Performs final batch disposition of semi-finished and/or finished drug product, to ensure high quality imaging agent (GMP Compliance) is released in a timely manner.Effectively review/approve GMP documents to ensure quality attributes are met (i.e.: qualification/validation protocols and reports, procedures, technical reports, change controls, deviations, OOS/OOT investigations, product quality complaints, master batch records, methods and specifications).

The position is essential for evaluating and negotiating GMP compliance at CMOs during new product qualification, validation, establishment of control strategy and manufacturing operations to ensure future NDA regulatory approval. Electronic batch records with high integration and focus on data integrity may be utilized to confirm manufacturing production.

Accountable for GMP quality related activities for imagining agent pipeline in clinical phase studies. This includes but not limited to CMO relationships, batch review/release, support of site transfers, and internal document set up/review, QMS team meetings, and participation ion CMC / CMO meetings. In addition, support team and management for facilitating transition from drug development to commercial product.

Essential Job Duties

• Act as the Quality liaison within the FI CMC team and across CMO sites, working closely with manufacturing, QC (Quality Control) and regulatory members for delivery of drug product to clinical studies.
• Review and approve change controls, deviations, failure investigations, and product quality complaints related to manufacturing, testing, holding, and distribution of drugs.
  • Ensure GxP compliance, document observations are communicated to responsible parties, and execute corrective actions promptly.
  • Audit, verify data, review, and resolve comments on manufacturing documentation (e.g., deviations, changes, procedures, protocols, batch records, specifications, methods, training documents), escalating for management approval as needed.
• Perform final batch disposition of Active Pharmaceutical Ingredient (API), semi-finished and/or finished drug product batches, to ensure high quality product (GMP Compliance) is released within expected metrics.
• Drive, mentor and coach personnel on quality matters associated with the batch or batch disposition process.
• Ability to apply phase appropriate GMP compliance practices to quality outcomes.