Senior Specialist Q. A

4 days ago


Durham NC, United States Experis Full time

Job Title: Senior Specialist Q. A - Level I 
Duration: 12 Month Contract
Location: 
ONSITE - 100 Rodolphe Street, Bldg. 1300, Durham, NC 27712 
Shift: Sun-Thurs shift and Tues-Sat shift

Job Description:
Qualifications:

  • Quality control professional with a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 1-3 years’ experience in the Pharmaceutical Industry preferred
  • High school acceptable with equivalent experience and open to advanced degrees.
  • Must have working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products with experience in quality assurance oversight of sterile manufacturing.
  • Experience with environmental monitoring is TOP skillset.
  • Water sampling/filtration experience, utility monitoring, and aseptic technique heavily preferred.
  • SAP and/or GLIMS experience are nice to have skills.
  • Previous gowning experience, LAL/Endotoxin testing experience, Process monitoring also preferable skillsets.
  • A mix of individual tasks but also working together as a holistic team.
  • Strive for attention to detail, team player.
Responsibilities:
  • Responsible for environmental monitoring in aseptic environment, collection and processing of water samples, component and product release testing.
  • Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills.
  • Must have very strong relationship building skills.


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