Associate Specialist, Quality

Job Description

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.

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
• One (1) years laboratory testing or equivalent educational laboratory
• Work independently and within a team environment
• Good communication
• Aseptic techniques
• Must be able to work the following schedule: Tuesday to Saturday 8-hour day shift, weekend and holiday coverage schedule may vary.

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
• 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.

VETJOBS #EBRG

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:08/28/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R308585