Assoc. Spclst, Quality Control

Merck & Co. • Eno Valley, NC

201d • $63,900 - $100,500 • Onsite

About The Position

Our Company is expanding its global vaccine production by adding an end to end laboratory capability located in the Durham, NC campus. The facility will be used to produce the bulk active ingredient, finished product. The Associate Specialist, Quality Control participates in a team of analysts in the development, validation, and routine testing. The position will focus on microbiology and sterility testing for commercial production. The successful candidate will work on assay development, assay validation, equipment validation, and GMP laboratory readiness. The Quality Operations Laboratory Specialist performs laboratory testing on a variety of product samples, including bulk vaccine, filled vaccine, and media. The successful candidate will support the microbiology testing laboratories with emphasis on microbiological methods such as sterility bioburden, and endotoxin. The successful candidate will also be expected to review and authorize testing results, collaborate in day-to-day lab scheduling, provide leadership in lean lab initiatives, have a strong understanding of Labware Laboratory Information Management System (LIMS), handle Quality Notification authoring and provide audit support.

Requirements

• B.S. degree in a science field required, preferably biology, microbiology, or biological sciences.
• Good technical writing skills and high attention to detail.
• One (1) year laboratory testing or equivalent educational laboratory.
• Work independently and within a team environment.
• Good communication.
• Aseptic techniques.

Nice To Haves

• Knowledge of cGMP and cGDP.
• Experience handling and manipulating BSL-1 and BSL-2 microorganisms.
• Compendia microbiological testing methods.
• Bioburden testing.
• Endotoxin (LAL) testing.
• Growth Promotion.

Responsibilities

• The emphasis is on microbiological methods, such as sterility, endotoxin, and bioburden.
• Has knowledge of cell aseptic technique and standard microbiological procedures for BSL-1 and BSL-2 laboratories.
• Perform data review of laboratory test data and associated records.
• Trouble-shoots equipment issues as needed.
• Initiates and contributes to laboratory investigations as needed and follows site procedures in the documentation of Quality Notifications and Preventative Actions.
• Collaborates with Durham Laboratory Compliance to ensure adherence to regulatory requirements.
• Provides active support during audits and inspections (regulatory, internal, safety).
• Supports our Company's Manufacturing Division (MD) divisional and Quality initiatives.

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree