Quality Control Specialist

Quality Control Specialist page is loaded## Quality Control Specialist remote type:
Onsite locations:
Durham, NCtime type:
Full time posted on:
Posted Todayjob requisition :
R26-3

Ask Bio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease.

Ask Bio’s gene therapy platform includes Pro
10, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing.
** Our vision:
** Pioneering science to create transformative molecular medicines.
** Our mission:
** Lead innovative science and drive clinical outcomes to transform people's lives.
** Our principles:
*** Advance innovative science by pushing boundaries.
* Bring transformative therapeutics to patients in need.
* Provide an environment for employees to reach their fullest potential.
** Our values:
*** Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
* Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
* Embrace Responsibility. We are humbled by the enormity of our mission.  We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
* Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
* Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.
** Position Summary
** The Quality Control Specialist is an entry level opportunity within the Quality Control organization at Ask Bio.  This individual will perform routine GMP testing activities in a regulated gene therapy manufacturing environment.  This position is responsible for analytical testing using established methods, preparing reagents and solutions, and supporting the maintenance of cell lines used across multiple clinical programs.  The QC Specialist plays a critical role in ensuring data integrity, compliance and operational excellence within the QC laboratories.

The
** Quality Control Specialist**, reporting to the Manager of Quality Control, will be an office-based position in RTP, NC.
** Job Responsibilities
*** Perform routine analytical testing including but not limited to cell-based potency assays, ddPCR, qPCR, ELISAs, limit tests using HPLC techniques
* Prepare solutions and maintain cell lines for various clinical programs
* Prepare laboratory solutions, maintains cell lines, and other day to day laboratory activities
* Maintain laboratory documentation including logbooks, test forms, LIMS data, and electronic data
* Assist with revisions of work instructions, SOPs, forms, reports, and electronic laboratory notebook analytical records
* Assist with management of analytical test method supplies and samples as needed
* Ensure lab areas are clean and organized, maintaining equipment and consumables
* Work closely with Analytical Development, Quality Control, Quality Assurance, Production staff and any other relevant departments
* Strictly adhere to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents, both internal and external
* Participate in continuous improvement projects in the AD and QC labs
* Support revisions to work instructions, SOPs, forms, protocols, and reports
** Minimum…