Specialist, Quality Control Analytical

About the role

The Specialist, Quality Control Analytical will advise testing laboratories on method development, validation, transfer, and quality investigations. They will also manage supplier change notifications and controls, generate purchase requests and orders, and assist in tracking and trending data.

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 certificates of analysis
• 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

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.

Qualifications

• 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.
• In-depth knowledge of USP, EP and ICH guidelines.
• Knowledge and understanding 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.

Skills

• 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.
• In-depth knowledge of USP, EP and ICH guidelines.
• Knowledge and understanding 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.

Benefits

ImmunityBio offers a comprehensive benefits package including:

• Medical, Dental and Vision Plans
• 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) including: 11 Holidays

Pay

The hourly base pay range for this position is $42.85 (entry-level qualifications) to $47.12 (highly experienced) per hour.

Schedule

This position works on-site. Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval. Flexibility in working schedule, i.e., off-hours, second shift, and weekends is possible. This position is eligible for a discretionary bonus and equity award.