Quality Assurance Associate – Quality Control (Data Review)

Location
San Diego, CA
Posted
Sep 28, 2021
Ref
2021-6281
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

Imagine… 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives.

 

This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapy are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

 

We use cutting-edge technology to turn promising gene therapies into proven treatments beginning with SMA but also focusing on Rett Syndrome and Friedreich's Ataxia.

 

Imagine the lives you could transform by joining the Novartis Gene Therapy team.

 

The Quality Assurance (QA) Associate will support the monitoring and verify that the processes used to manage and create the deliverables have been followed and are operative.  Quality Assurance for Quality Control (QC) provides the necessary quality oversight of quality control functions to ensure compliance with all standards, procedures and specifications.

Responsibilities

  • Provide quality assurance oversight and independent review for quality control analytical activities, including review/approval of test records, testing and stability protocols and reports, and documentation supporting product disposition (i.e. certificates of testing, certificates of analysis).
  • Provide quality assurance oversight for quality control compliance including standard operating procedures, non-conformances, laboratory investigations, corrective/preventive actions, and change controls.
  • Support activities associated with event resolution and CAPAs.
  • Implement and ensure adherence of appropriate regulations and quality standards relative to quality control.
  • Write, review and approve Standard Operating Procedures (SOPs), Quality Impact and Risk Assessments (QRAs), Quality Plans, and specifications, as needed.
  • Support training program for QC analysts for lab specific quality systems and compliance (e.g. QA review and approval of training plans).
  • Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance.

Qualifications

  • BS in Pharmacy, Biotechnology, Chemistry or another science/engineering-based field.
  • BS with 1-year QA related experience and 2-3 years' experience in QC/lab.  
  • Related experience should be in GMP regulated industries in quality assurance and/or compliance or equivalent. Related experience in supporting an operational quality control lab.
  • Working knowledge of regulatory (e.g. FDA, EMEA) requirements, as well as industry quality management tools, standards, and quality systems.
  • Understanding of pharmaceutical industry and cGMP experience is required, with knowledge and understanding of manufacturing, quality control, and validation requirements and activities.
  • Works precisely according to procedures, rules and regulations, has a passion for continuous improvement and quality.
  • Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the Company.

The level of this position will be based on the final candidate's qualifications.

 

Why Novartis?

 

769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

 

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

 

Imagine what you could do here at Novartis!

 

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 

 

Novartis Gene Thereapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-RM1

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