Gmp, Quality Assurance Associate Ii

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Job Title: GMP, Quality Assurance Associate II

Primary role:

Quality Assurance (QA) is responsible for ensuring that components, intermediates, drug substance, and drug product are of the quality required for their intended use and that quality systems are maintained. With minimal oversight and/or independently, the QA Associate II will perform a variety of duties associated with the Office of Regulatory Affairs and Quality in support of the GMP programs at Duke University, including, but not limited to, release of products/clinical trial material, assistance with deviations and event management, review of vendor qualifications, analysis of environmental monitoring data, training on GMP requirements, and oversight of component control and disposition. This position will consult with manufacturing operations staff, as applicable/requested, to serve as a resource. Additionally, provide technical guidance and support for engineering, equipment, and validation in support of GMP manufacturing. This position will be focused on support for the Marcus Center for Cellular Cures (MC3) GMP Facility at Duke University and will consult with manufacturing operations staff, as applicable/requested, to serve as a resource. This position reports to the Associate Director, Quality Assurance.

Essential tasks/responsibilities:

With minimal oversight by management or independently

• Represent the Quality Department at project meetings and provide guidance.
• Collaborate with end users about deviations, issues, and unexpected events that may arise.
• Participate in multiple programs in varying phases of development or that require varying levels of QA involvement.
• Conduct audits under the supervision of the Lead Auditor, and generate audit reports.
• Track and trend metrics and identify areas of concern.
• Train staff on proper GMP, performing investigations, and root cause analysis.
• Review and provide guidance for deviations and investigations.
• Provide support and review of change control as it relates to development, modification, and manufacturing process changes.
• Write, revise, and review SOPs.
• Assist in managing quality related matters during inspections.
• Review product records for release.
• Conduct Environmental Monitoring of facilities and assist in data analysis.
• Assist with continuous improvement projects and initiatives.

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Education/training:

Required: Bachelor’s degree in life sciences, or a related field of study.

Preferred: None

Experience:

Required:

• 5 years of experience in a GXMP or similar regulated environment.
• Prior laboratory experience preferred.
• A Master's or PhD can substitute for experience except as related to validation and/or technical quality engineering support of manufacturing operations.
• Experience in reviewing raw materials, supplies, and manufactured products for acceptability. Experience with validation and/or technical quality engineering support of manufacturing operations.
• Validation and/or technical quality engineering support of manufacturing operations is required for this position.
• Experience in preparing for external audits and/or site visits.
• Experience training users on implementing Quality Systems.

OR ANY OTHER EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Skills:

Required:

• Team player with sense of urgency to carry out tasks in a timely and accurate manner.
• Possess good problem-solving skills.
• Strong organizational skills.
• Adapt to changing priorities effectively.
• Demonstrate leadership, organizational, and time management skills and the ability to handle a multitude of tasks.
• Attention to detail in document review.
• Ability to interact well with employees at all levels.
• Able to work effectively independently or in a team environment.
• Excellent verbal, written, and interpersonal skills.
• Have ability to train other staff members effectively.
• Proficient knowledge in GLP, GMP, and/or GTP.

Preferred:

• Has served as final signature for QA release of raw materials and finished products.
• Has served as QA department representative at various functions and report back to the QA department.

Duke is an Affirmative Action/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, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, 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 essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.