Specialist, Quality Control Analytical
ImmunityBio•El Segundo, CA
•Onsite
About The Position
The Specialist, Quality Control Analytical will serve as Subject Matter to advise testing laboratories on method development, method validation, method transfer, and quality investigations. Primary duties will include data review and troubleshooting of analytical test methods.
Requirements
- Bachelor's degree with 6+ years relevant experience in Analytical Chemistry or related discipline required; or Master's degree with 4+ years of experience in Analytical Chemistry or related discipline required.
- Experience in method development, method validation, method transfer, lot release tests, stability programs and specification development required
- Strong knowledge of quality control analytical method development, method validation and method transfer.
- Strong technical writing skills to author SOPs, analytical tests methods, qualification/validation protocols/ reports.
- Knowledge and understanding of USP, EP and ICH guidelines.
- In-depth knowledge of GMPs and pharmaceutical regulations.
- Ability to communicate effectively with internal functions both in writing and verbally.
- Ability to collaborate with contract testing laboratories, consultants, ensuring compliance with company procedures.
- Ability to multi-task and prioritize.
- Strong problem solving and computer skills.
Responsibilities
- Author, review and revise documentation (SOPs, test methods, analytical method development, method validation, method transfer protocols/ reports, product specifications)
- Review QC stability and lot release data (data integrity check) and CoAs issued by contract testing laboratories and create batch release certificate of analysis
- Author and review laboratory OOS investigation and invalid laboratory test result, including filing internal Quality Systems reports as applicable.
- Issue ImmunityBio release Certificates of Analysis (CoAs) to support QA lot disposition activities.
- Author, review and revise Analytical Section of documents such as the IND, BLA for regulatory CMC submission
- Provide technical expertise to troubleshoot analytical methods
- Manage suppliers change notifications and change controls
- Generate Purchase Requests and Purchase Orders for contract testing laboratories projects
- Ensure timely escalation of quality control related issues
- Assist QC-Analytical management in tracking and trending data
- Collaborate with other departments (e.g. QA and Regulatory) for quality control related duties
- Attend QC-Analytical internal meetings and external meetings with contract testing laboratories
- May conduct other duties, as assigned
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
