successfactors
Quality Control Associate I, GMP
Duke University
Durham, USA
Mid
Onsite
Discovered 4 days ago
Communication
Key Skills for This Role
Communication
Full Job Posting
Skills
- Required: Knowledge and hands on classwork with analytical methods and/or product formulation. Hands on experience with analytical methods (GMP product release testing and/or Product characterization testing), molecular or pharmaceutical product formulation (buffer & excipient screening, thermal stability evaluation, biophysical methods) is preferred. GMP experience is a plus Must have the ability to work independently with guidance from senior scientists/management. Demonstrated ability in solving moderately complex analytical problems with guidance from senior management. Strong oral and written communication skills Must be able to manage multiple and rapidly changing priorities and have ability to quickly learn new skills and concepts. Preferred: Knowledge and hands on classwork with analytical methods and/or product formulation. Experience working in or with a Quality Department Experience with Environmental monitoring Experience in a GMP environment Experience in preparing for external audits or site visits A Master's or PhD can substitute for experience This position is Onsite. The work is performed on-site or at a designated assignment location. Be Bold. As a GMP Quality Control Associate I, you will: Perform analytical development, product characterization, and GMP release testing activities to support cellular therapy programs. Execute and document testing, method qualification, and technology transfer activities in compliance with GMP and regulatory requirements. Monitor the GMP facility through routine environmental monitoring activities to ensure continued microbial control and regulatory compliance. Investigate and support quality events, including deviations, CAPAs, non-conformances, out-of-specification results, and related documentation. Collaborate with manufacturing, process development, quality assurance, and external testing partners to ensure successful product development and release. Choose Duke. Join a team dedicated to developing next-generation cellular therapies that have the potential to transform patient care. You will work alongside talented scientists, manufacturing specialists, and quality professionals in a collaborative environment where innovation, quality, and patient safety are at the center of everything we do. At Duke, you'll have the opportunity to expand your expertise in GMP manufacturing, quality control, and advanced therapeutic development while contributing to groundbreaking research and clinical advancements that make a meaningful impact. Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $67,919.00 to USD $102,898.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer. Your total compensation goesbeyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/ Equal Opportunity Employer: Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender,gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy- related conditions), sexual orientation, or military status. Duke aspires to create a community built oncollaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values. Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and reasonable accommodation(s) can be requested with Duke Access and Accommodations Services (email: [email protected]; phone: 919-668-1267).
Preferred Qualifications
- Required: Knowledge and hands on classwork with analytical methods and/or product formulation. Hands on experience with analytical methods (GMP product release testing and/or Product characterization testing), molecular or pharmaceutical product formulation (buffer & excipient screening, thermal stability evaluation, biophysical methods) is preferred. GMP experience is a plus Must have the ability to work independently with guidance from senior scientists/management. Demonstrated ability in solving moderately complex analytical problems with guidance from senior management. Strong oral and written communication skills Must be able to manage multiple and rapidly changing priorities and have ability to quickly learn new skills and concepts. Preferred: Knowledge and hands on classwork with analytical methods and/or product formulation. Experience working in or with a Quality Department Experience with Environmental monitoring Experience in a GMP environment Experience in preparing for external audits or site visits A Master's or PhD can substitute for experience This position is Onsite. The work is performed on-site or at a designated assignment location. Be Bold. As a GMP Quality Control Associate I, you will: Perform analytical development, product characterization, and GMP release testing activities to support cellular therapy programs. Execute and document testing, method qualification, and technology transfer activities in compliance with GMP and regulatory requirements. Monitor the GMP facility through routine environmental monitoring activities to ensure continued microbial control and regulatory compliance. Investigate and support quality events, including deviations, CAPAs, non-conformances, out-of-specification results, and related documentation. Collaborate with manufacturing, process development, quality assurance, and external testing partners to ensure successful product development and release. Choose Duke. Join a team dedicated to developing next-generation cellular therapies that have the potential to transform patient care. You will work alongside talented scientists, manufacturing specialists, and quality professionals in a collaborative environment where innovation, quality, and patient safety are at the center of everything we do. At Duke, you'll have the opportunity to expand your expertise in GMP manufacturing, quality control, and advanced therapeutic development while contributing to groundbreaking research and clinical advancements that make a meaningful impact. Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $67,919.00 to USD $102,898.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer. Your total compensation goesbeyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/ Equal Opportunity Employer: Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender,gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy- related conditions), sexual orientation, or military status. Duke aspires to create a community built oncollaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values. Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and reasonable accommodation(s) can be requested with Duke Access and Accommodations Services (email: [email protected]; phone: 919-668-1267).
About Duke University
Higher Education48313 employeesFounded 1838
Private research university and academic health system.
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