Specialist, Quality Control

Location
Durham, NC, US
Posted
Jul 22, 2021
Ref
6188
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
Overview

Imagine\u2026 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 Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

The Specialist, Quality Control, assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality processes and standards for manufacturing and production.

Responsibilities
  • Cell handling and potency testing
  • Assists in the evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
  • Reviews data obtained for compliance to specifications and reports abnormalities. Performs trend analysis of methods / environmental data / assay controls & standards and draws conclusions.
  • Capable of delivering to assigned work schedule with attention to detail and accuracy.
  • Support department risk assessments and participates in audit walk-throughs.
  • Conducts routine and non-routine analysis, including but not limited to biochemical and chemical analysis, of raw materials, in-process items and finished product according to established operating procedures.
  • Compiles data for documentation of test procedures that may include stability program testing and formulation studies.
  • Supports Quality Control department at QMR by preparing slide deck and presenting laboratory metrics.
  • Participates in the preparation of investigations, summaries and reports. Reviews data obtained for compliance to specifications and reports Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT/OOE and Investigation.
  • Authors new/revise Standard Operating Procedures, Protocols / Summary Reports /Analytical Master Plans for QC.
  • Oversees special projects on analytical and instrument problem solving. May develop testing and analysis methods and procedures in accordance with established guidelines.
  • Supports training of departmental personnel in appropriate technique and related topics.
  • Champion's continuous improvement projects to maximize laboratory efficiencies and to strengthen compliance.
  • Other related job duties as assigned.

Qualifications
  • Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field with 5 years' experience in GMP environment.
  • Direct experience in cell handling and potency testing
  • Full understanding of area of specialization; resolves a wide range of issues in creative ways.
  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
  • Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
  • Ability to receive little instruction on day-to-day work, general instructions on new assignments.
  • Networks with senior internal and external personnel in own area of expertise.
  • Excellent interpersonal, verbal and written communication skills with strong technical writing experience.
  • Possess a strong understanding of QC testing technique.
  • Proficient in Microsoft Word, Excel, Power Point and other applications.
  • Extensive knowledge of GLP and GDocP principles.
  • An understanding of FDA/EMEA regulations.


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!

Novartis Gene Therapies Benefit Summary:

Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.

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 Therapies 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-MG1