Manufacturing Quality Assurance Associate (2nd Shift)
Compensation: $78,130.00 - $122,480.00 /year *
Employment Type: Full-Time
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Ready to join a team committed to moving gene therapies into the clinical and commercial settings for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101 (ZOLGENSMA). We are in the midst of anincredible 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 the Quality oversight of manufacturing operations on the floor and working in collaboration with AveXis staff. The Manufacturing Quality Associate is 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 Associate will use risk based decision making to address any issues on the manufacturing floor and will serve as the quality point of contact for the operations. 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; reporting to management all necessary information from plant floor.
+ Work effectively with Operations, Maintenance, and Engineering on the floor and make on the spot, risk based decisions; escalate issues to management as necessary.
+ Real time on the floor Batch record and logbook review.
+ Support and review of SOPs/Documents: documentation, SOPs, instruction sets, specifications, batch record closure, etc. and other Quality procedures directly related to operations and other cGMP activities.
+ Ensure all Non-conformances from established procedures are appropriately documented and investigated to determine and fix root cause.
+ Non-conformance/CAPA Management support. Review and approve the non-conformance report, including batch/material disposition.
+ Complete on the floor quality audits and sampling during the manufacturing processes.
+ Ensure all required assessment and testing is carried out to support Quality approval or rejection, as appropriate, for starting materials, packaging materials, intermediates, bulk and finished product.
+ Disposition of incoming raw materials for use in production.
+ Provide quality input on the translation of commercial product requirements into a technical product profile that includes defining critical quality attributes (CQAs) and critical processing parameters (CPPs).
+ Ability to work the shift schedule of the posted position and lift approximately 25 lbs.
+ Willing and able to work other shifts (day, night, and/or weekend) as required in the event of training, projects, short-term coverage, and other circumstances.
+ Self-starter with a strong understanding of GMP requirements, acute attention to detail, and ability to assess risk to product quality and compliance.
+ Excellent oral and written communication skills with strong technical writing experience required.
+ A minimum of 3 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 CFRs and cGMPs.
+ Direct experience reviewing/executing batch records and standard operating procedures and partnering with operations on product related investigations and Non-conformances.
+ Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.
+ Knowledge of material control.
+ Ability to learn new electronic systems.
+ Experience with internal and regulatory audits (both FDA and international agencies) preferable.
+ Lean manufacturing / six sigma experience is a plus.
+ Experience with material disposition is a plus.
+ Experience with clinical manufacturing, viral gene therapies and/or orphan disease indications is a plus.
The Manufacturing Quality Associate position is for: Rotational 12 hour shift shedule (2-2-3-3 schedule) - 6:00 p.m. to 6:00 a.m.
Note this position will primarily work 1 st shift, Monday-Friday, for approximately the first 3 months of employment.
_The level of this position will be based on the final candidates qualifications._
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._
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**Job Locations** _US-NC-Durham_
**Posted Date** _1 month ago_ _(12/16/2019 2:29 PM)_
**_Job ID_** _2019-4512_
**_# of Openings_** _1_
Associated topics: biochemistry, bioengineering, biology, bioprocess, fermentation, hereditary, neuro, neuroscience, pain, pharmaceutical
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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