Senior Specialist Q. A - I

Job Title: Senior Specialist Q. A - I
Job Location: Durham, NC
Job Duration: 12 Months+
 
Shift: Sun-Thurs shift and Tues-Sat shift.
 
Job Description:

• 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

 
Requirements/ Qualification:

• 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.
• Have had success with candidates who worked at Pfizer in the past. Will work on a team of about 19. A mix of individual tasks but also working together as a holistic team. Strive for attention to detail, team player.
• Shift is mostly days but can include an early morning or later shift from time to time.
• 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.
• Have had success with candidates who worked at Pfizer in the past. Will work on a team of about 19.
• A mix of individual tasks but also working together as a holistic team. Strive for attention to detail, team player.
• Shift is mostly days but can include an early morning or later shift from time to time.

 
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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