Senior Quality Assurance Engineer

ImmunityBio, Inc. • Dunkirk, NY

3d • $108,000 - $120,000 • Onsite

About The Position

ImmunityBio, Inc. is a commercial-stage biotechnology company focused on developing cell and immunotherapy products to enhance the patient's natural immune system to combat cancer and infectious diseases. The Senior Quality Engineer will manage and perform various Quality Engineering activities to support company objectives, providing expertise in validation, calibration, risk management, and facility maintenance programs in a phase-appropriate manner.

Requirements

• Bachelor’s degree in engineering, Biomedical Engineering, Chemical Engineering, Biotechnology or other relevant science degrees is required.
• 5+ years of experience in the pharmaceutical/biopharmaceutical industry is required.
• 2+ years of experience in related Quality Engineering is required.
• Strong knowledge of biologics cGMP manufacturing.
• Strong knowledge of cGMP facility design, control, and automation.
• Proven ability to work independently, analyze, and resolve issues.
• Attention to detail with strong analytical and problem-solving skills.
• Ability to operate in a fast-paced, multi-disciplinary industrial environment while managing multiple priorities.
• Exceptional organization, flexibility, and time-management skills with ability to deliver under deadlines.
• Familiarity with risk management activities per ISO14971, ISO31000, or ICH Q9.

Nice To Haves

• Experience in aseptic processing is preferred.
• Experience supporting internal/external compliance and regulatory audits is preferred.
• Prior statistical software experience is preferred.
• Experience with GAMP 5 preferred.
• Basic lab skill knowledge (cell culture, pipetting, dilutions, titrations, etc.) preferred.
• Statistical Process Control (SPC) or Six Sigma experience preferred.

Responsibilities

• Independently review and approve equipment, facility, and instrument IQ/OQ/PQ and process validation protocols and reports.
• Independently review and approve Computer System Validation protocols and reports.
• Assess validation, qualification and/or requalification, calibration, and maintenance requirements of all GMP equipment, instruments, and facilities in collaboration with equipment owners.
• Review, revise, and approve Standard Operating Procedures, study protocols, and reports.
• Perform risk analyses using tools such as, but not limited to, Hazard Analysis, FMEA, FTA, HACCP, etc.
• Perform statistical analysis, where appropriate and based on risk, to support various studies.
• Provides training on risk assessments and statistical process control.
• Perform or support CAPAs arising from engineering and validation issues.
• Perform root cause analysis with tools such as, but not limited to, Ishikawa, A3, 5 Whys, Is – Is not, using six sigma DMAIC methodology, etc.
• Identify and support continuous improvement projects in collaboration with different functional group management to achieve quality, reliability, and efficiency improvement objectives.
• Conducts internal auditing activities to ensure that systems are operated per established SOPs and GMPs.
• Supports preparation for regulatory agency inspections and participates as a Subject Matter Expert during regulatory GMP inspections if required.
• Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters that arise are addressed in an open and timely manner.
• Supports and actively engages to achieve department and site goals and objectives.
• Organize and manage data relating to Quality Engineering activities.
• Provide status reports, including relevant quality metrics.
• Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
• Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.

Benefits

• Medical, Dental and Vision Plan Options
• Health and Financial Wellness Programs
• Employer Assistance Program (EAP)
• Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
• Healthcare and Dependent Care Flexible Spending Accounts
• 401(k) Retirement Plan with Company Match
• 529 Education Savings Program
• Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
• Paid Time Off (PTO) includes: 11 Holidays
• Exempt Employees are eligible for Unlimited PTO
• Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day

What This Job Offers

• Job Type: Full-time
• Career Level: Senior