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Product Quality Specialist

Manpower Engineering is looking for a Product Quality Specialist. This is a 6+ month contract opportunity. Details as follow:

Job Title: Product Quality Specialist

ONSITE - SHIFT - M-F 1ST - DURATION - 6 MONTHS WITH POSSIBILITY OF EXTENSION - EDUCATION - Bachelor of science degree in related field (Chemistry/Engineering/Pharmaceutical Science). EXPER - 2-3 years of experience in the pharmaceutical industry in Quality function.

The position is responsible for coordinating overall operations of the Quality Assurance function as related to specific assigned products and customers at the Morrisville site.

I. Essential Functions:

1. Primary quality liaison for clients and internal customers
2. Subject Matter Expert for the client products, processes and requirements.
3. Approval of Product Quality related customer complaint investigations
4. Approval of Events, Deviations, CAPAs (manufacturing)
5. Author Annual Product Review (APR) documents and trend reports
6. Effectively coordinates functions of internal QA organization with customers and necessary Catalent departments. Specifically: reviewing and closure of investigations (major and minor deviations), reviewing and closure of non-critical customer complaints, reviewing executed batch records and support data, performing trending of product specific data, review and approval of Master Batch Records, and author applicable sections of the Annual Product Review/Annual Quality Review.
7. Responsible for supporting internal, client, and regulatory audits through coordination and/or leadership of the audit backroom.
8. Other duties as assigned.
Knowledge/Skills Requirements:
1. High level of attention to detail.
2. Proficient in problem solving, analytical skills and critical thinking.
3. Proficient in technical investigations, batch record review and technical writing
4. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
5. Review documentation for accuracy and completeness.
6. Strong computer and appropriate communication skills (both written and oral) allowing direct interaction with external clients and RTP internal staff.
7. Demonstrated ability to read, write, and speak clear English.

Physical Requirements:
1. Frequent sitting, walking, reading of written documents and use of computer monitor screen, writing, talking, carrying, listening

Business Environment:
1. Fast-paced
2. Performance driven
3. Customer focused
4. Collaborative and inclusive

Recruiter: Cristal Smith


Salary Range
$45,000.00 - 77,000.00
per Year
Salary range estimated by
Morrisville, NC 27560, US