Senior Quality Assurance Engineer

About the role

The Senior Quality Engineer at ImmunityBio is responsible for managing and performing a wide variety of Quality Engineering activities in support of activities needed to meet company objectives. The role provides Quality Engineering support and expertise for the maintenance and enhancement of quality and compliance aspects of validation, calibration, risk management, and facility maintenance programs.

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.
• Performs or supports CAPAs arising from engineering and validation issues.
• Conducts 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.
• Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
• Perform ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.

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.
• 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.

Qualifications

• 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.
• Basic lab skill knowledge (cell culture, pipetting, dilutions, titrations, etc.) preferred.
• Statistical Process Control (SPC) or Six Sigma experience preferred.

Benefits

ImmunityBio offers a competitive total rewards benefits package, including:

• 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

Pay

The annual base pay range for this position is $108,000 (entry-level qualifications) to $120,000 (highly experienced) annually.

Schedule

This position works on-site. Exposure to an onsite in-lab environment is required. Must be able to don and wear Personal Protective Equipment (PPE) as required. Lifting, standing, climbing, bending, grasping, sitting, pulling, pushing, stooping, stretching, and carrying are generally required to perform the functions of this position. Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer. Must be able to lift frequently up to 35 pounds and occasionally lift/move 50 pounds.