Talent.com
Quality Assurance Engineer
Quality Assurance EngineerNovartis Group Companies • Durham, North Carolina, United States
Quality Assurance Engineer

Quality Assurance Engineer

Novartis Group Companies • Durham, North Carolina, United States
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Job Description Summary

The Quality Assurance Engineer is responsible for the design, construction, validation, maintenance and overall compliance of facilities, systems and processes at Novartis Gene Therapies, Durham, N.C.

Job Description

Location :

  • This position will be located in Durham, NC and will be able to work on Hybrid schedule

Key Responsibilities :

  • Provides QE support for clinical and commercial gene therapy products.
  • Support of all internal and external audits in support of product manufacturing.
  • Ensures Quality and Compliance aspects of design and work in collaboration with Engineering, technical functions, Manufacturing Operations to ensure that the facility is :
  • Compliant with all appropriate regulations (e.g. FDA, EMEA and other major health authorities) for GMP manufacturing.

  • Capable of manufacturing products that are safe, effective and that meet all applied controls and specifications.
  • Capable to meet intended design goals of output volume, turnaround time and operating and product costs.
  • Provides input on the translation of commercial product requirements into technical solutions that are capable of meeting defined CQAs (product Critical Quality Attributes) and CPPs (Critical Process Parameters).
  • Acts as Quality approver on project deliverables, as defined in the project plan.
  • Works with validation colleagues to define the initial asset life-cycle model and qualification and validation strategy, to ensure successful validation of the facility.
  • Authors and / or approves Standard Operating Procedures in support of project activity and deliverables.
  • Provides QA oversight of engineering, validation, and facilities activities related to maintaining a GMP facility in a validated state.
  • Acts as the Quality approver for change controls, deviations, and CAPAs required to maintain the manufacturing facility in a GMP state.
  • Works with supplier and Vendor Management colleagues to ensure that suppliers of goods and services for the new manufacturing facility are compliant and capable of fulfilling their contracted requirements.
  • Essential Requirements :

  • B.S. degree in preferably engineering, chemistry or biochemistry.
  • 5 years' experience in Biotech / Pharmaceutical industry or 4 years' experience in Biotech / Pharmaceutical industry, with at least 2 years within Novartis Gene Therapies.
  • Experience with viral gene therapies, cell culture technologies and / or orphan disease indications is a plus.
  • Strong knowledge and application of the CFR's and cGMPs.
  • Comprehensive knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.
  • Direct experience with commissioning, qualification and validation to meet FDA and other health authority requirements.
  • Experience with deviations, CAPAs, and Change Controls.
  • Direct experience reviewing and / or authoring standard operating procedures and partnering with operations on product related investigations and deviations.
  • Excellent oral and written communication skills with strong technical writing experience required.
  • Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward
  • Novartis Compensation and Benefit Summary :

    The salary for this position is expected to range between $85,400 and $158,600 annually.

    The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

    Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

    US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

    #LI-Hybrid

    EEO Statement :

    The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

    Accessibility and reasonable accommodations

    The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to or call and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

    Salary Range

    $85,400.00 - $158,600.00

    Skills Desired

    Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence

    [job_alerts.create_a_job]

    Quality Assurance Engineer • Durham, North Carolina, United States

    [internal_linking.related_jobs]
    Quality Assurance Manager (1790)

    Quality Assurance Manager (1790)

    Kooner Fleet Management Solutions • Durham, NC, US
    [job_card.full_time]
    About Kooner Fleet Management Solutions.Kooner Fleet Management Solutions is one of the fastest-growing national providers of on-site fleet maintenance, preventative service, and mobile repair solu...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Locum Physician (MD / DO) - Anesthesiology - General / Other in Roxboro, NC

    Locum Physician (MD / DO) - Anesthesiology - General / Other in Roxboro, NC

    LocumJobsOnline • Roxboro, NC, US
    [job_card.full_time] +1
    LocumJobsOnline is working with CompHealth to find a qualified Anesthesiology MD in Roxboro, North Carolina, 27573!.Some locum assignments can be as short as a day, others, years.Some are far from ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Restaurant Delivery - Start Earning Quickly

    Restaurant Delivery - Start Earning Quickly

    DoorDash • Roxboro, NC, United States
    [job_card.full_time] +1
    DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day. As a Dasher, you’ll stay busy with a variety o...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Quality Assurance Engineer

    Quality Assurance Engineer

    VirtualVocations • Durham, North Carolina, United States
    [job_card.full_time]
    A company is looking for a Quality Assurance (QA) Engineer.Key Responsibilities Partner with teammates and developers to advance software quality Build product test strategies, write and execute...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Quality Manager

    Quality Manager

    Freudenberg Group • Durham, NC, US
    [job_card.full_time]
    Working at Freudenberg : We will wow your world!.Manage and continuously improve the QMS to ensure compliance with ISO 9001 standards and other relevant industry certifications.Plan and execute inte...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    REGISTERED NURSE SUPERVISOR (RN) - ROXBORO HEALTHCARE & REHABILITATION CENTER

    REGISTERED NURSE SUPERVISOR (RN) - ROXBORO HEALTHCARE & REHABILITATION CENTER

    Liberty Health • Roxboro, NC, US
    [job_card.full_time]
    REGISTERED NURSE SUPERVISOR (RN) - ROXBORO HEALTHCARE & REHABILITATION CENTER.Liberty Healthcare and Rehabilitation Services. We are currently seeking an experienced : .REGISTERED NURSE SUPERVISOR...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Nuclear Engineer

    Nuclear Engineer

    US Navy • Durham, North Carolina, United States
    [job_card.part_time]
    It takes hard work and smarts to get you into the reactor room.But if you have a strong interest in math, chemistry, physics and engineering, you might just have what it takes to be a Machinist's M...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Principal Test Engineer

    Principal Test Engineer

    Zoetis, Inc • Durham, NC, United States
    [job_card.full_time]
    Zoetis is currently looking for a Principal Test Engineer to join our team in Durham, NC.The Principal Test Engineer is a key position in the development and validation of devices for the animal he...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Quality Assurance Associate

    Quality Assurance Associate

    Randstad USA • Durham, NC, United States
    [job_card.full_time]
    Quality Assurance Associate, Solution Lot Records (Contractor).We are seeking a detail-oriented and highly organized.Research Triangle Park (RTP) facility. This is a critical, on-site role focused o...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Quality Assurance I (Intern) - United States

    Quality Assurance I (Intern) - United States

    Cisco Systems, Inc. • Research Triangle Park, North Carolina, United States
    [job_card.full_time]
    Please note this posting is to advertise potential job opportunities.This exact role may not be open today but could open in the near future. When you apply, a Cisco representative may contact you d...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Sr CQV Engineer / Sr Validation Engineer (Holly Springs)

    Sr CQV Engineer / Sr Validation Engineer (Holly Springs)

    EPM Scientific • Holly Springs, NC, United States
    [job_card.full_time]
    Senior Validation Engineer / CQV Specialist.Greenville, NC / Holly Springs, NC.A leading pharmaceutical manufacturing organization is seeking a few. Senior Validation Engineers / CQV Specialists.The...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    CQV Engineer

    CQV Engineer

    PSC Biotech • Durham, NC, us
    [job_card.full_time]
    [filters_job_card.quick_apply]
    PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all appl...[show_more]
    [last_updated.last_updated_variable_days]
    Senior Specialist Quality Assurance III

    Senior Specialist Quality Assurance III

    Spectraforce Technologies • Durham, NC, United States
    [job_card.full_time]
    Senior Specialist Quality Assurance III.Quality Assurance professional with at a minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 5 years e...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Quality Assurance Engineer

    Quality Assurance Engineer

    Foxconn Industrial Internet - FII • Durham, NC, US
    [job_card.full_time]
    [filters_job_card.quick_apply]
    Durham, North Carolina , United States Employment Type : Full-time Overview : We are seeking a Quality Assurance Engineer to join our team and ensure the reliability and performance of refurbis...[show_more]
    [last_updated.last_updated_30]
    Senior Quality Assurance Engineer

    Senior Quality Assurance Engineer

    Insurance Office of America • Durham, NC, US
    [job_card.full_time]
    Title : Senior Quality Assurance Engineer – IOA Technology.Fully Remote for candidates in EST / CST time zones.Please note : If this position is posted as either fully remote and / or hybrid, in accordan...[show_more]
    [last_updated.last_updated_variable_hours] • [new]
    Quality Assurance Representative - QAR - Pharmaceutical Inspection

    Quality Assurance Representative - QAR - Pharmaceutical Inspection

    FST Technical Services • Holly Springs, NC, US
    [job_card.full_time]
    [filters_job_card.quick_apply]
    We are looking for Quality Assurance / Inspector Representatives with experience in Welding / Piping to join our teams in the Holly Springs, NC area ! This is a position for candida...[show_more]
    [last_updated.last_updated_30]
    Quality Assurance Engineer

    Quality Assurance Engineer

    Novartis • Durham, North Carolina, United States
    [job_card.full_time]
    This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.The Quality Ass...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Quality Assurance Specialist

    Quality Assurance Specialist

    Mentor Technical Group • NC, US
    [job_card.full_time]
    [filters_job_card.quick_apply]
    Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutio...[show_more]
    [last_updated.last_updated_30]