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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) year 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 or Sunday to Thursday, 8-hour or 10-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

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

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, Monday - 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”.

The salary range for this role is

$63,900.00 - $100,500.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include 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. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day, 2nd - Evening

Valid Driving License:

No

Hazardous Material(s):

N/A

Required Skills:

Adaptability, Analytical Instrumentation, Assay, Bioburden Testing, Biological Sciences, Cell-Based Assays, Chemical Analysis, Data Analysis, Finished Products, GMP Compliance, Laboratory Information Management System (LIMS), Laboratory Instrumentation, Laboratory Techniques, Microbiological Analysis, Microbiological Cultures, Microbiological Test, Microbiology, Teamwork, Technical Writing, Working Independently

Preferred Skills:

Job Posting End Date:

06/13/2025

*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:** R352790