Temporary - Senior Associate, QC Stability and Reference

Essential Functions

• Performs stability and reference coordination activities such as test forecasting, test scheduling, data entry, data trending, protocol and report drafting
• Coordination and/or packing of stability and reference materials for shipment
• Maintenance of controlled documents with stability reporting data
• Maintain logs for stability and reference material, including inventory logs
• Afford assistance with updates for applicable modules of IND, BLA, or any other regulatory submission
• Maintains equipment and completes maintenance records for stability chambers
• Support quality systems and documentation by completing change requests, updating SOPs and associated documents
• Performs other duties as assigned

Education & Experience

• Bachelor’s degree in Biology or related field required
• 2+ years’ experience within a quality control testing setting in the Biotechnology industry required
• Experience in GMP required

Knowledge, Skills & Abilities

• Excellent organization skills and attention to detail
• Strong interpersonal and written and oral communication skills
• Excellent problem solving skills
• Ability to thrive in an efficient, highly interactive, goal-oriented team environment
• Efficient Microsoft Word, PowerPoint and Excel skills
• Knowledge of cGMP, FDA, ICH and USP regulations
• Basic understanding of statistics

Working Environment / Physical Environment

• Position is an on-site position
• Exposure to onsite lab environment
• Flexibility in working schedule may be required to complete work on off-hours in order to complete deadlines
• Ability to pack, ship, and receive stability and reference standards on site
• Lift and carry materials weighing up to 20 pounds

Pay

The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location. $35.50 (entry-level qualifications) to $39.00 (highly experienced) per hour

Schedule

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

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

Equal Opportunity Employer

We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.