DATAEXL INFORMATION LLC · 8 hours ago
Quality Assurance Quality Control Engineer
United States
Contract
Remote
Senior Level
5+ years expDATAEXL INFORMATION LLC is seeking a highly motivated individual to join their team as a Sr. Specialist in the Quality Assurance (QA) department. This position will be responsible for ensuring quality of cGMP activities at external contract organizations for aseptically produced investigational cell and gene therapy products.
Information Technology & Services
Hiring Manager
ASHISH VARMA
Responsibilities
Lead cGMP QA compliance activities at external CxOs for all relevant operations, including raw material testing, GMP manufacturing, QC testing, release, stability, packaging/labeling, lot disposition and clinical supply activities for aseptically produced investigational cell and gene therapy products
Oversee quality aspects for commissioning, qualification and validation activities for equipment, batch record review, deviation handling and quality event processes at external CxOs
Support complex external OOS investigations, manufacturing investigations, change controls and implementation of CAPAs at external CxOs and internally, when applicable
Liaise with external QA representatives and maintain external relationships
Maintain knowledge of current industry standards and trends in best practices for compliance with cGMP regulations
Qualification
Required
Bio-Pharma experience (Client name)
Cell Gene Therapy Experience
Aseptic Process experience from a full process experience, not just doing but managing a team
QA experience, not just qc
Working with external manufacturing and contract organisations
Technology Transfer Experience
Batch record Experience
Biotech/Pharma Experience not healthcare and not consulting partners
Looking for a specialist not a jack of all trades
QA/QC experience
Mid Level cGMP experience
Experience working with third part partners
CAPA experience
Regulatory experience in regards to FAS
Life Sciences-based BSc or advanced degree with a minimum of 5 years' experience in pharma, biopharma or biotech with demonstrated knowledge of relevant cGMP regulations and QA operations in a GMP-regulated environment
Strong knowledge of GMP application to production and QC testing of biologics and aseptic processing, preferably with experience in cell and gene therapy
Strong knowledge of regulations and industry standards, including cGMP and applicable guidance documents, ICH guidance documents, USP, Ph. Eur, ISO and associated global regulations
Ability to support teams in meeting aggressive project timelines and to constructively engage team members in resolving conflicts
Highly adaptable and skilled problem solver with a proactive attitude comfortable with ambiguity
Ability and willingness to work in alternate time zones, if required (ie. early morning, late evening, possibly overnight)
Preferred
Experience working with CxOs and contract testing labs
Company
DATAEXL INFORMATION LLC
DATAEXL INFORMATION LLC is a women-owned business enterprise IT staffing and solutions partner since 2021.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase