Quality Assurance Specialist 4

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.
  • Familiarity of pharmaceutical product manufacturing processes.
  • Experience with Phase I thru IV, particularly Phase III; experience with Regulatory approval, NDAs and MAAs.
  • Ability to transition phase 3 clinical stage material to commercial success.
• Partner with cross-functional groups and CMOs to manage receipt, review, approval, and storage of documents provided by CMOs.
• Foster an exceptional quality culture by maintaining open communications and promoting synergy and employee participation.
• Resolve compliance issues/questions and escalate critical compliance issues.
• Contribute to the development, revision, implementation, and maintenance of GxP quality systems and SOPs.
• Support the establishment and revisions of Quality Agreements with CMO affiliates.
• Maintain Quality Management System status and provide periodic updates for open deviations, CAPA, change control, investigations, batch record review, CMO document review, drug product-related complaints, and other systems as assigned.
• Provide inputs for the continuous monitoring of GMP compliance of the product lifecycle, including evaluation of CMO quality incidents and escalation to Senior Management as risks arise.
• Other duties as required.

Required Skills and Experience

• Deep knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance.
• Previous batch disposition experience supporting parenteral and drug substance products/materials.
• Well-developed technical expertise of quality systems and regulatory requirements.
• Experienced in root cause analysis techniques.
• Ability to effectively manage and prioritize challenging priorities and communicate appropriately, both verbally and in writing, to various audiences. Demonstrated attention to detail.
• Ability to organize and prioritize multiple tasks, demonstrating flexibility when faced with changing priorities.
• Previous experience with regulatory inspection readiness and execution preferred.
• Advocate for training and knowledge sharing.
• Proven computer skills in various software packages (e.g., Visio, eDMS such as SmartSolve/Trackwise/ZenQMS, MS Word, PowerPoint, Excel, Gantt).

Required Education and Training

• Minimum B.Sc. Degree in Life Sciences or Engineering field
• Minimum of 8+ years of experience in the pharmaceutical industry
• Minimum of 6 years of direct Quality Assurance experience in regulated industry, pharma/biotech

Working Conditions

• Position requires extensive reading, writing and computer-based work.
• Ability to travel up to 10% for meetings and coordination with global or existing manufacturing sites
• Qualified candidates must be legally authorized to be employed in the United States. Position does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this position.

Preferred Skills and Experience

• CQA certification from the American Society for Quality (ASQ).
• Experienced with Laboratory Information Management System (LIMS).
• GCP experience.

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Employment Opportunity / Affirmative Action Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

EEO and AA Policy

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.