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GMP, QUALITY ASSURANCE ASSOCIATE I

Job description


diversity employer



GMP, QUALITY ASSURANCE ASSOCIATE I
Regulatory

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 consult with
manufacturing operations staff, as
applicable/requested, to
serve as a resource. This position reports to the Director of
Regulatory Affairs and Quality.

Requisition Number
401503993

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
FULLTIME

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

Auto req ID

105757BR

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.

PI106087993

 

 

 

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Job No:
Posted: 12/8/2018
Application Due: 2/6/2019
Work Type:
Salary: