GMP, QUALITY CONTROL ASSOCIATE II (Durham, NC, US, 27710)

Duke University
 Durham, NC

School of Medicine:

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Job Title: GMP, Quality Control Associate II

Primary role:

The GMP, Quality Control Associate II will support the development, qualification and execution of analytical methods to enable release of cellular products. With minimal oversight and/or independently, this position will be executing specialized testing of cellular products for clinical trials and commercial operations, supporting GMP production of cellular products and therapeutics. In addition, this individual will be responsible for environmental monitoring of the GMP facility, and projects manufactured therein, to ensure it is in control and in compliance with applicable regulations. The individual filling this position will be an integral member of a team working together to produce the highest quality clinical and commercial material for novel cellular therapies. This position will consult with manufacturing operations staff, as applicable/requested, to serve as a resource.

Essential tasks/responsibilities:

With minimal oversight by management and/or independently:

  • Perform pharmaceutical development and successful GMP release including: Analytical development, assisting the QC Manager and Product Development team in development of specific release and characterization methods
  • Aid in qualifying methods for product release and complete comprehensive characterization of clinical lots.
  • Complete GMP testing in line with ICH and regulatory guidance.
  • Lead qualification testing of cellular therapy products including, tech transfer and associated testing under GMP conditions.
  • Execute and document development and GMP activities in compliance with regulatory requirements.
  • Collaborate closely with other development teams to provide support for development activities and will work diligently with other development functions to understand how the production process changes impact product quality.
  • Compile data and perform analysis and interpretation and draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making; summarize data, present results and propose next steps to advance development.
  • Write and review development reports; write protocols for use in GMP facility and SOPs for GMP production, and present data to project teams and larger settings.
  • Write, coordinate, and review QC deviations, non-conformances, CAPAs, out of specifications, complaints, and all associated required reporting.
  • Ship and prepare samples for outside vendors for quality control testing. Engage external vendors for coordination of quality control testing.
  • Operate and maintain equipment utilized in characterization and qualification testing.
  • Perform routine environmental monitoring of the GMP Facility to ensure facility remains in state of microbial control.
  • Execute activities and serve as key resource for junior staff in a cleanroom environment while following associated GMP and regulatory guidelines.
  • Independently support project teams for Quality Control input and contributions on event/deviation composition, including associated investigations, assessment for impact/risk, root cause analysis, and CAPA requirements/documentation
  • Represent the Quality Control Department at project meetings and provide guidance.
  • Track and trend Quality Control metrics and identify areas of concern.
  • Participate in multiple programs in varying phases of development or that require varying levels of Quality Control involvement.
  • In conjunction with the QC Associate Director, develop, write, and review analytical, equipment and process validations.

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

Experience:

Required:

  • 5 years of experience in a GXMP or similar regulated environment.
  • Experience in training Quality personnel
  • Prior laboratory experience in product testing.
  • Experience in preparing for external audits and/or site visits.
  • Experience in reviewing raw materials, test and analytical method results, 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 QC release of test and analytical method results, raw materials and finished products.
  • Has served as QC department representative at various functions and report back to the QC department
  • Experience in leading laboratory investigations and/or CAPA(s)

Special competencies/credentials:

Required: None

Preferred: None

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 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.

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