Associate, Quality Control Analytical

ImmunityBio, Inc.El Segundo, CA
31d$32 - $35Onsite

About The Position

The Associate, Quality Control Analytical in the Quality Control department is responsible for ensuring the timely execution of Quality Control Analytical assays in support of product release across all of ImmunityBio’s oncology and vaccine product platforms. This position will train on and perform a variety of molecular biology, and/or chemistry assays including but not limited to cell culture, qPCR, flow cytometry, cytotoxicity, visual inspection and/or Compendial test methods in the evaluation of product quality.

Requirements

  • Bachelor’s degree in a life sciences discipline with 1+ years of relevant experience required.
  • Proficient communicator (written and verbal)
  • Ability to proactively take initiative to remove roadblocks that interfere with the completion of assigned tasks
  • Able to be timeline focused
  • Proficient in Microsoft Word, Project, and Excel
  • Strong problem-solving skills with demonstrated attention to detail
  • Strong verbal, written, and interpersonal communication skills
  • Proficiency in computer use and Microsoft Office applications
  • Attention to detail with strong analytical and problem solving skills
  • Well-developed written and oral communication skills
  • Motivated to work in a team environment
  • Ability to perform troubleshooting and develop solutions to problems of moderate scope in complexity
  • Ability to operate in a fast-paced, multi-disciplinary industrial environment
  • Ability to work efficiently in a highly interactive, goal-oriented team environment
  • Able to be flexible in order to meet the demands of a multi-product clinical phase biopharmaceutical company.
  • Exceptional organization and time-management skills
  • Ability to multi-task across multiple functional areas and retain flexibility in a dynamic environment
  • Consistently deliver on commitments
  • Ability to manage up to fifty (50) pounds at a time and stand for extended periods of time while wearing appropriate clean room gowning material and appropriate personal protective equipment is required.

Nice To Haves

  • Experience in a GMP regulated Biologics or Pharmaceutical environment is preferred.
  • Knowledge of cell and molecular biology, immunology, and/or virology is preferred.
  • Experience in cGMP aseptic processing facility is preferred.
  • Good understanding and demonstration of aseptic techniques is preferred.

Responsibilities

  • Ensure and support a safe working environment for work areas.
  • Perform testing of assigned lot release and stability samples to meet expected turnaround time requirements.
  • Participate in method qualification, validation and transfer activities.
  • Support instrument installation and operational qualification activities (IOQ).
  • Ensure a compliant workspace by adhering to and enforcing GxP requirements.
  • Ensure the integrity of all data generated.
  • Maintain laboratory equipment, supplies and inventory inclusive of cleaning and sanitization of equipment and restocking of supplies.
  • Assist in authoring and working collaboratively on documentation such as protocols, reports, SOPs and test methods as needed.
  • Ensure timely escalation of all assay related challenges/issues and assist in developing countermeasures to improve performance.
  • Track / trend key performance indicators and identify adverse events in testing and escalate as needed to prevent reoccurrence.
  • Participate in continuous improvement activities to help improve the overall operations of the testing labs.
  • Maintain analytical laboratory in a state of control, compliance, and inspection readiness.
  • Interface with all auditors (internal and external) to ensure positive audit outcomes.
  • Partner with colleagues in various departments (e.g., AD/PD, Facilities, Engineering, QA and Regulatory) to ensure achievement of company goals.
  • Adheres to Standard Operating Procedures (SOPs) and cGMP guidelines.
  • Performs ad-hoc and cross-functional duties and/or projects as 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
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