GMP, QUALITY ASSURANCE ASSOCIATE I

Location
Durham, NC
Posted
Apr 13, 2017
Institution Type
Four-Year Institution

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, inspection/release of materials, qualification of critical suppliers, review of batch records for 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 directly to the Duke Human Vaccine Institute CGMP Program (DGP) Manager of the Quality Systems Unit (QSU) and overall to the Director of Regulatory Affairs and Quality of the Duke University School of Medicine.

Essential tasks/responsibilities:

In conjunction with other members of the QA Staff and/or Management:
• Track and trend metrics and identify areas of concern
• Write, revise, and review SOPs
• Assist in managing quality-related matters during internal/external inspections
• Prepare QSU Quality reports
• Lead continuous improvement projects and initiatives
• Attend meetings with Quality personnel
• Assist with Deviation/Event management including corrective action and preventative action (CAPA) management and root cause analysis (RCA)
• Develop, compose, and review analytical, equipment and process validations
• Conduct environmental monitoring of facilities
• Assist with material/component inspection and control
• Participate in internal facility/process/data audits
• Assist with batch review/release

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
401249326

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, 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.

Education
Required: Bachelor's degree

Experience
Required:
2 years of experience in quality assurance and/or quality control, preferably related to GMP. Experience in early clinical phase vaccine manufacturing a plus.

Preferred:
• Experience in CAPA management and RCA
• Experience in preparing for/hosting external audits or site visits
• Experience in material/component inspection and release
• Experience in batch record management/review
• Working knowledge of GMP
• Organizational and time management skills with the ability to handle a multitude of tasks.
• Working knowledge of electronic databases.
• Attention to detail.
• Ability to work independently or in a team environment
• Excellent verbal, written, and interpersonal skills conducive to interactions with team members at all levels.
• Possess good problem-solving skills

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

Auto req ID

88862BR

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.

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