DurhamRecruiter Since 2001
the smart solution for Durham jobs

Quality Control Specialist (PCR) - 2nd Shift

Company: AveXis Inc.
Location: Durham
Posted on: November 11, 2019

Job Description:

Overview Ready 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 Quality Control Specialist (PCR) provides expertise at the AveXis GMP Manufacturing facility. This includes technical writing, routine testing, and all other associated activities. The Specialist responsibilities include, but are not limited to, training, sampling, routine testing, method qualification/validations, investigations, and technical writing. A potential candidate will possess a strong understanding of QC testing techniques. Additional responsibilities include adherence to all GMP requirements, a thorough understanding of FDA/EMEA regulations, effective interactions/communication with Quality management, and personal development. The Specialist may also support the Manager for activities related to interviewing and training of employees, compliance with GMP, and identifying and implementing corrective and preventive actions. The Specialist should be able to work effectively within the group, within Quality, and across site. Responsibilities Perform established analytical methods such as ddPCR (Digital PCR) and qPCR (Quantitative PCR) for in-process, release, or stability samples. Serve as subject matter expert for multiple assays representing Quality Control during audits and inspections. Perform data review, trending and data analysis. Conduct thorough investigations to determine root cause of OOS investigations and other non-conforming results and implement appropriate corrective and preventative actions in a timely manner. Liaise with other departments including Quality Assurance, Manufacturing and Facilities to address compliance issues and to implement corrective actions and to improve programs. Participate in assay troubleshooting, qualification and validation. Manage the use and maintenance of scientific equipment and instrumentation, computer systems. Write and revise documents such as SOPs and technical reports. Qualifications Minimum B.A. or B.S. in scientific related field. Minimum of 5 years in a GMP Quality Control laboratory. Strong knowledge of multiple assays. Strong experience with method validation and qualification. Experience leading small teams and projects. Thorough understanding of Root Cause Analysis Self-reliant, a good problem solver and results-oriented, and comfortable working in a fast-paced environment. An excellent and persuasive communicator. Energetic, flexible, collaborative and proactive. Ability to work rotating shift Ability to work overnight shift The level of this position will be based on the final candidate's 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.

Keywords: AveXis Inc., Durham , Quality Control Specialist (PCR) - 2nd Shift, Other , Durham, North Carolina

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Dedicated Truck Driver - Home Weekly!
Description: HOME DAILY Dedicated Truck Driver Opportunity - Runs out of Henderson, NC Ride with U.S. Xpress today We are now hiring drivers for dedicated runs out of Henderson, NC with DAILY HOMETIME and 2 Days (more...)
Company: U.S. Xpress
Location: Wilson
Posted on: 11/17/2019

School School Services - Special Education Teacher - $1,570 per week
Description: NurseFly Travel Nursing with Ardor Health Solutions Therapy is seeking a special education teacher for a travel job in Danville, Virginia: br - Specialty: Special Education Teacher br - Discipline: (more...)
Company: NurseFly Travel Nursing
Location: Danville
Posted on: 11/17/2019

DoorDash Delivery Driver - No Experience Needed - Danville
Description: No passengers. No bosses. Just you, your tunes, and the road. Sign up now and start making money Choose your wheels and deliver food and other items from local merchants to
Company: Doordash
Location: Danville
Posted on: 11/17/2019


Travel Nurse RN - Cardiac Cath Lab - $1,711 per week
Description: NurseFly Travel Nursing with Travel Nurses, Inc. is seeking a cardiac cath lab travel nurse for a travel nursing job in Danville, VA: br - Specialty: Cardiac Cath Lab br - Discipline: RN br - Start (more...)
Company: NurseFly Travel Nursing
Location: Danville
Posted on: 11/17/2019

CDL-A Truck Driver - Sign-On Bonus Available- $68K-70K Avg. Pay!
Description: Professional CDL-A Delivery Driver br br br Twice the Opportunities br br We have two distribution centers in Rocky Mount - br br each with great, but different delivery opportunities. (more...)
Company: McLane Company
Location: Wilson
Posted on: 11/17/2019

Bid On Local Remodeling Jobs - Reach New Customers In Your Area
Description: Over 25 million homeowners have trusted HomeAdvisor 1800Contractor to help them find quality professionals with the expertise to turn their home improvement
Company: HomeAdvisor
Location: Wilson
Posted on: 11/17/2019

Travel Nurse RN - Oncology - $1,825 per week
Description: NurseFly Travel Nursing with Advanced Travel Nursing is seeking a oncology travel nurse for a travel nursing job in Danville, Virginia: br - Specialty: Oncology br - Discipline: RN br - Start Date: (more...)
Company: NurseFly Travel Nursing
Location: Danville
Posted on: 11/17/2019

Medical-Surgical Travel RN
Description: Jackson is adding to our Med/Surg team and needs Registered Nurses experienced at caring for adult patients with general medical conditions or who have undergone surgical procedures to fill 13 week contracts (more...)
Company: Jackson Nurse Professionals
Location: Wilson
Posted on: 11/17/2019

Get New Roofing Work Today - Preview Leads In Your Area
Description: Over 25 million homeowners have trusted HomeAdvisor 1800Contractor to help them find quality professionals with the expertise to turn their home improvement
Company: HomeAdvisor
Location: Wilson
Posted on: 11/17/2019

Travel Speech Language Pathologist - $1,512 per week
Description: NurseFly Travel Nursing with Advanced Travel Therapy is seeking a travel speech language pathologist for a travel job in Wilson, North Carolina: br - Specialty: Speech Language Pathologist br - Discipline: (more...)
Company: TherapyFly Travel Therapy
Location: Wilson
Posted on: 11/17/2019

Log In or Create An Account

Get the latest North Carolina jobs by following @recnetNC on Twitter!

Durham RSS job feeds