IB Temporary - Associate, Quality Control Analytical
About The Position
The IB Temporary - Associate 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 Immunity Bio’s oncology and vaccine product platforms. This position requires expertise with molecular biology and/or chemistry assays utilizing cell culture, ELISA, HPLC, icIEF and CE-SDS techniques. The position requires experience with analytical development as well as qualification/validation of GMP quality control assays. This role will interact cross-functionally with members of the Manufacturing, Quality Assurance, Analytical Development, and Process Sciences teams.
Requirements
- Bachelor’s degree in a life sciences discipline with 3+ years of relevant experience required.
- Strong knowledge of analytical molecular biology assays preferred.
- Experience with the technical transfer and qualification/validation of analytical assays preferred.
- Fundamental knowledge of cell and molecular biology, immunology, and virology.
- Strong technical writing skills with experience preparing: SOPs, analytical tests reports, qualification/validation protocols, qualification/validation reports, and summary reports to support FDA and EMA filings.
- Strong problem-solving skills with demonstrated attention to detail.
- A demonstrated knowledge and understanding of 21 CFR 210/211, USP, EP and ICH guidelines.
Responsibilities
- Ensure and support a safe working environment for work areas.
- Lead the 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 work space by adhering to and enforcing GxP requirements.
- Support and/or lead out of specification and out of trend investigations and implement corrective actions as needed to prevent reoccurrence.
- Approve testing performed by other team members to ensure timely release of test data.
- Ensuring the integrity of all data generated.
- Provide technical expertise for test methods and help troubleshoot invalid assays when needed to improve assay performance.
- 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 and/or lead 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.
- May conduct other Quality Control related duties as assigned.
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
- We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
