Associate Specialist, Quality -Durham, NC

Job Description

The Associate Specialist, Quality Control participates in a team of analysts in the development, validation, and routine testing intermediate and final product samples. 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.

Primary 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

Education Minimum Requirement:

• B.S. degree in a science field required, preferably biology, microbiology, or biological sciences

Required Experience and Skills:

• Good technical writing skills and high attention to detail

• 1 year of laboratory testing or equivalent educational laboratory

• Work independently and within a team environment

• Good communication

• Aseptic techniques

• Schedule Monday through Friday, 1st shift.

Preferred Experience and Skills:

• Knowledge of cGMP and cGDP

• Experience handling and manipulating BSL-1 and BSL-2 microorganisms

• Compendia microbiological testing methods

• Bioburden testing

• Sterility testing

• Endotoxin (LAL) testing

• Growth Promotion

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. #EBRG VETJOBS

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: