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QA Specialist
1 month ago
The Scientific Team at Russell Tobin & Associates is supporting an exciting pharmaceutical organization that has an opening for a Remote QA Specialist.
Responsibilities
- Performs batch record review and release of drug products at CMO
- Provides quality documents to regulatory affairs and clinical operations
- Support technical transfer activities – ensure compliance of labeling, packaging, and distribution operations at CMO
- Support quality aspects related to cold chain distribution
- Serves as quality contact to support nonconformance investigations, CAP implementation and change control, document revision and product complaints related activities
- Additional duties as assigned
Requirements
- Bachelor's degree in Engineering or Life Science
- 5+ years of related pharmaceutical or biotech industry experience in GMP regulated environment – product packaging
- Experience with contract manufacturing organizations
- Strong knowledge in 21 CFR 210/211, 21 CFR 1271, and 10 CFR 810, EudraLex volume 4, and ATMPs preferred
- Very good communication skills
Additional Notes:
- Remote position – could be required to travel onsite to California location for audits
- Shift: Monday-Friday 9am-5pm
- Must be flexible with work schedule – may occasionally require off hours and weekend work
- Position type: 6+ month contract with potential for extension
- Pay rate range approved: $40-48/hr depending on experience
Must be authorized to work in the United States.
Russell Tobin offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.
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About Us
Russell Tobin is a leading minority-owned professional and technical recruitment and staffing advisory organization.
We are comprised of specialized practices focusing on a variety of skill sets and industries. Having a depth and breadth of industry expertise, our subject matter experts are able to provide tailored and swift sourcing solutions to fulfill client hiring needs. In other words, we connect top talent with companies.
We are the staffing arm of the Pride Global network, a minority-owned integrated human capital solutions firm, with additional offerings in vendor management, payroll programs, and business process optimization.
As a certified minority-owned business, Pride Global and its affiliates - including Russell Tobin, Pride Health, and Pride Now - are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other characteristics.
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Company DescriptionRussell Tobin is an equal-opportunity employer and values diversity in the workplace. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.Company DescriptionRussell Tobin is an equal-opportunity employer and values diversity in the workplace. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
