98 applicants
Theragent Inc · 2 days ago
Senior Quality Engineer
Arcadia, CA
Full-time
Onsite
Senior Level
5+ years exp
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Responsibilities
Implement and manage the QMS program, including but not limited to Change Control, Deviations, CAPA, Compliance/Audits, Supplier Quality Management, QA Validation, and Risk Management, that is phase appropriate to support cutting edge technologies for cell and gene therapy.
Perform daily QA operations to support site GMP production.
Conduct investigation and assessment in a timely manner to ensure the delivery of high-quality product as a CDMO.
Ensure compliance with CGMP regulations, guidance, and industry standards.
Lead the risk management process for site risk analysis per ICH Q9. Deploy quality risk management principles to ensure appropriate risk mitigation and control is exercised.
Perform Internal and External supplier audits and inspections and support all client and agency inspections.
Maintain the audit program as well as audit findings and reports to be completed in an accurate and timely manner.
Build, teach, and act as a quality resource for a team with varying experience levels.
Participates in cross-functional teams as an experienced Quality technical resource. Making risk-based, scientifically and/or statistically sound, quality/regulatory compliant decisions.
Implementation, roll-out, and maintenance of the electronic Quality Management System in a phase appropriate manner for the company.
Support hosting client/regulatory inspections, inspection readiness, and reviewing audit reports and responses, as needed.
Maintaining company state of inspection readiness.
Responsible for the authoring or review and approval of controlled documentation including Policies, SOPs, Work Instructions, Quality Records, and other controlled document types.
Facilitate the compiling, trending and reporting of key quality system metrics for management, and other technical operations functions.
Provide project management leadership for QA department projects/initiatives as needed.
Lead continuous improvement of department processes, realizing efficiency gains, and ensuring team continues to meet expanding business needs with lean resources.
Partner closely and communicate with other Operations groups to resolve issues, identify and close gaps, and seek quality compliant outcomes which are efficient and robust.
Ability to multitask and to readily shift priorities based on immediate needs.
Other duties as assigned by upper management
Qualification
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Required
Expert knowledge of FDA CFR Parts 11, 210, 211 and 1271, ICH Q8/Q9/Q10; EudraLex Volume 4 Part 4: ATMP and/or other applicable regulations
Strong knowledge of CGMP regulations and QA Operations in the biotech industry
Demonstrated ability to independently evaluate quality matters and make complex decisions by leveraging technical experience and analysis/synthesis of data
Strong hands-on, project management skills
Bachelor’s degree in biology, biochemistry, or related life science field
Minimum of 5 years of industry experience in Quality and in a GMP environment
Preferred
Experience with implementation and training in Quality Management Systems and other electronic quality systems
Experience in cell and gene therapy industry preferred
Strong written and verbal communications skills
Strong organizational and time management skills
Proficient in Microsoft Office Suite
Experience in commonly used industrial software systems, i.e. Trackwise, LIMS, E-Document Control, E-training, etc
Company
Theragent Inc
Theragent Inc is a startup biotechnology company that specializes in developing and manufacturing novel personalized immunotherapies for cancer patients around the world.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Jeff Masten MBA
Chief Operating Officer
Recent News
Company data provided by crunchbase
