Senior Quality Engineer
4 weeks ago
The Senior Quality Engineer will be the technical lead for quality assurance functions including operations, quality management systems management, and validation. This individual will provide expertise and guidance in interpreting regulations, agency guidelines, internal policies, and audits and assessments. conduct supplier audits and assessments to ensure compliance. This position must work with people across all functions and levels of the organization including inside and outside of Theragent.
Primary 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.
- 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
Reports to: Quality Assurance Manager
FLSA Status: Exempt
Location: Arcadia, CA
Knowledge, Skills & Abilities:
- 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.
- Ability to work outside of precedent and take a new perspective on existing solutions.
- Excellent interpersonal skills with experience dealing with a diverse workforce.
- Self-starter with the ability to effectively manage and track multiple tasks/projects simultaneously to completion.
- Strong hands-on, project management skills.
- 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.
- 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.
- Experience with implementation and training in Quality Management Systems and other electronic quality systems.
- Experience in cell and gene therapy industry preferred.
Travel: Occasional. Less than 10%
Working Conditions:- Fully onsite and able to provide off-hour production shifts as needed.
- Primarily office environment but will be required to enter laboratory or GMP processing areas donning proper gowning/lab coats and other PPE.
- Clean room manufacturing and laboratory environment.
- Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs.
- Ability to sit, stand, walk and move within workspace for extended periods
- Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling
- Ability to work safely and effectively when working alone or working with others
This description outlines the basic responsibilities and requirements for the position noted. This is not a comprehensive listing of all job duties of position. Duties, responsibilities, and activities may change at any time with or without notice.
Theragent, Inc. is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status. All qualified applicants will receive consideration for employment.
Theragent, Inc. requires employees to be vaccinated against COVID-19. To the extent permitted by applicable law, candidate must be able to provide proof of full vaccination or receipt of the first dose of a two-dose COVID- 19 vaccine, or request an exemption due to a medical reason, a sincerely held religious belief of practice, or pregnancy, as of the first day of work, to be considered for a U.S.-based job.
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