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GMP, QUALITY ASSURANCE ASSOCIATE II
Job Title: GMP, QUALITY ASSURANCE ASSOCIATE II
Job Code: 2771
FLSA: E
Job Level: 85
Revised Date: 03/01/2017
Job Family: JF 05
Occupational Summary
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.
Work Performed
Essential tasks/responsibilities:
With minimal oversight by management or independently: -Provide support and review of change control as it relates to development, modification, and manufacturing process changes. -Represent the Quality Department at project meetings and provide guidance. -Write, revise, and review SOPs. -Assist with continuous improvement projects and initiatives. -Track and trend metrics and identify areas of concern. -Assist in managing quality related matters during inspections. -Review and provide guidance for deviations and investigations. -Collaborate with end users about deviations, issues, and unexpected events that may arise. -Train staff on proper GMP, performing investigations, and root cause analysis. -Review product records for release. -Participate in multiple programs in varying phases of development or that require varying levels of QA involvement. -Conduct Environmental Monitoring of facilities and assist in data analysis. -Conduct audits under the supervision of the Lead Auditor, and generate audit reports.
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.
Required Qualifications at this Level
Education/Training
Bachelor's Degree required
Experience
Required: -5 years of experience in a GXMP or similar regulated environment. -Experience training users on implementing Quality Systems. -Prior laboratory experience preferred. -Experience in preparing for external audits and/or site visits. -Experience in reviewing raw materials, supplies, and manufactured products for acceptability.
A Master's or PhD can substitute for experience
Skills
Required: -Proficient knowledge in GLP, GMP, and/or GTP -Demonstrate leadership, organizational, and time management skills and the ability to handle a multitude of tasks. -Have ability to train other staff members effectively. -Attention to detail in document review. -Team player with sense of urgency to carry out tasks in a timely and accurate manner. -Ability to interact well with employees at all levels. -Strong organizational skills. -Excellent verbal, written, and interpersonal skills. -Possess good problem-solving skills. -Adapt to changing priorities effectively. -Able to work effectively independently or in a team environment. 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
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University 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 essential job 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.
