Senior Manufacturing Quality Assurance Specialist (MQA)

Senior Manufacturing Quality Assurance Specialist (MQA)

24 Jun 2024
North Carolina, Durham 00000 Durham USA

Senior Manufacturing Quality Assurance Specialist (MQA)

Vacancy expired!

OverviewReady to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene.The successful candidate will be responsible for supporting the design, implementation, and continuous improvement of robust Quality Systems for a new viral gene therapy manufacturing site and quality on the manufacturing floor. The MQA Sr. Specialist will use risk based decision making to serve as the quality SME for processes, electronic systems, and quality systems across all aspects of the site. Will provide critical quality expertise to transition a novel gene therapy into a commercially approved product. Willcontribute to the key plant metrics for the Quality Management Review meeting (QMR) to ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics.Responsibilities

Work effectively with cross-functional groups as a stakeholder, SME, and project lead on initiatives including continuous improvement, gap assessments, quality risk assessment, non-conformances, technical transfers, etc.

Non-conformance/CAPA Management support. Review and approve non-conformance reports. Mentor investigators and approvers on the investigation process and technical writing.

Support Manufacturing QA shift personnel through problem solving quality issues on the floor and training/mentoring.

Support and review of documentation, SOPs, instruction sets, specifications, batch record closure and other Quality procedures directly related to operations and other cGMP activities.

Disposition of incoming raw materials for use in production.

Independently lead projects to address quality gaps or drive continuous improvement related to Operations or Quality Systems. Capable of summarizing, analyzing and presenting data/information clearly to management to drive efficient decision making.

Develop standard work to implement risk based quality oversight program for Operations and ensure routine activities are completed within established timelines.

Qualifications

Self-starter with a strong understanding of GMP requirements, acute attention to detail, and ability to assess risk to product quality and compliance.

Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.

Excellent oral and written communication skills with strong technical writing experience required.

A minimum of 5 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, purification or aseptic fill/finish.

Minimum B.S. degree in preferably engineering, microbiology, chemistry or biochemistry or 5 years equivalent industry experience.

Strong knowledge of and application of the CFR’s and cGMP’s. Able to navigate the procedural hierarchy from CFRs to Global Documents to Site Level Documents/Work Instructions.

Direct experience writing or approving major investigation reports with potential product quality impact. Able to apply multiple root cause analysis tools.

Experience interacting with internal and regulatory auditors (both FDA and international agencies).

Ability to lift approximately 25 lbs.

Willing to work other shifts on as needed basis (day, night, and/or weekend) in the event of training, projects, short-term coverage, and other circumstances.

Lean manufacturing / six sigma experience is a plus.

Experience with clinical manufacturing, viral gene therapies and/or orphan disease indications is a plus.

Experience with material disposition is a plus.

The Manufacturing Quality Sr. Specialist position is for: Monday-Friday (normal business hours)Limited routine travel. May involve position specific travel or brief assignment during facility startup.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.AveXis 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-TT1Need help finding the right job?We can recommend jobs specifically for you!Job Locations US-NC-DurhamPosted Date 4 hours ago (6/24/2020 6:00 PM)Job ID 2020-5277# of Openings 1Category Quality

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