GMP, QUALITY ASSURANCE ASSOCIATE I

Location
Durham, NC
Posted
Jun 09, 2018
Institution Type
Four-Year Institution

diversity employer



GMP, QUALITY ASSURANCE ASSOCIATE I
Regulatory

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 assistance and oversight, the QA Associate I 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
critical review of deviations and investigations, review/revision of SOPs, release of materials, qualification
of critical suppliers, review of product release, audit of programs under ORAQ's purview, and quality
training.

This position will be focused on support the Carolinas Cord Blood Bank and the Clinical and
Translational Cellular Therapy (CT2) 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 Director of
Regulatory Affairs and Quality.

Essential tasks/responsibilities:

In conjunction with other members of the QA Staff and/or Management:
Write, revise, and review SOPs.

Participate in Environmental Monitoring of facilities, as applicable. Work to recognize concerning
trends associated with these data and alert management.

Learn about auditing and participate in audits with the Lead Auditor.

Support material/component inspection and control.

Perform batch record review and product release.

Conduct routine QC record review for program. Identify any errors/deficiencies and ensure that
these are communicated to applicable personnel and resolved as efficiently as possible.

Assist with tracking and trending metrics and identify areas of concern.

Assist in managing quality related matters during inspections and support maintenance of
inspection ready programs.

Prepare Quality reports, as applicable.

Assist with continuous improvement projects and initiatives. Learn to recognize and propose
resolutions to identified gaps in the quality systems.

Attend meetings with Quality personnel. Participate in departmental meeting and actively engage
other members of Quality in determining a resolution to the presented topics.

Facilitate event management issues with programs. Work collaboratively with the Director and
with end users on investigating, documenting, and proposing resolutions to these events (such as
deviations) in a timely manner. Ensure that follow up and corrective actions are being performed
and documented appropriately. In conjunction with the Director, develop, write, and review
analytical, equipment and process validations.

Assist with other quality functions, as requested.

Develop collaborative relationships with operational personnel and be a resource for them
regarding questions on all GMP quality systems.

Work closely with Quality management to implement and enhance new and existing quality
systems as directed.

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.


Requisition Number
401359839

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
2770 GMP, QUALITY ASSURANCE ASSOCIATE I

Job Family Level
14

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
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.

Education

Required: Bachelor's Degree

Experience

Required: 2 years of experience in a laboratory or regulated field, preferably related to GMP. Preferred: - Experience in preparing for external audits or site visits. - Experience working in or with a Quality Department. A Master's or PhD can substitute for experience.

Preferred:

Experience in preparing for external audits or site visits.
Experience working in or with a Quality Department.

Skills:
Required:
• Working knowledge of GLP, GMP, GTP
• Have, organizational, and time management skills and the ability to handle a multitude of
tasks.
• Working knowledge of electronic databases.
• Attention to detail.
• Ability to handle multiple projects simultaneously.
• Able to work effectively independently or in a team environment
• Ability to interact well with employees at all levels.
• Strong organizational skills.
• Excellent verbal, written, and interpersonal skills.
• Possess good problem-solving skills


Auto req ID

95876BR

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.

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.

PI102869462

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