Job Description

The Specialist - Quality Control, within Laboratory Operations, under the broad direction from the Associate Director, will be responsible for the implementation and management of laboratory equipment and automated systems utilized within assigned laboratories. The incumbent assures operation in accordance with our Manufacturing Division and Company safety policies and procedures, cGMP regulations, and within the departmental budget. Responsibilities can include providing technical expertise and recommendations on Company, Divisional and Organizational projects such as capital requests, operational improvements, instrument repair, SDLC and IOQ documentation and execution, and run the business activities in support of all testing conducted within LO.

Responsibilities:

• Provides technical support as needed to other testing sites within our network including partnerships with sites in Durham, NC and Haarlem, NL to help ensure operational alignment of test methods and equipment including support for analytical method transfers.

• Supports capital projects and coordinate equipment projects for assigned area within Laboratory Operations.

• Works directly with the Engineering, Maintenance and Utilities team to prioritize and schedule preventative and corrective maintenance.

• Initiates new equipment and instrument change control, SDLC and IOQ documentation and executes accordingly.

• Initiates and participates in equipment related investigations and quality notifications to ensure compliance with cGMPs and regulatory requirements to support the quality, safety, efficacy, and

• potency of our products.

Education Minimum Requirement:

• High school diploma.

Required Experience and Skills:

• A minimum of 1 year of experience in relevant laboratory, manufacturing, biotechnology or quality control experience in a related field.

• Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment

Preferred Experience and Skills:

• Proven analytical aptitude, critical thinking skills, and ability to apply key concepts.

• BS/B.A or M.S in Biology, Biochemistry, Chemistry, Engineering, Microbiology, Virology or another associated field.

• Demonstrated technical experience in analytical testing methodology, equipment and/or software validation principles.

• Speaks with courage and candor.

• Strong written and verbal communication skills.

• In-depth working knowledge and application of GMPs/GLPs.

• Ability to manage multiple projects simultaneously.

MSJR

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.

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U.S. Hybrid Work Model

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".

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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:

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Hazardous Material(s):

Job Posting End Date:

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Requisition ID:R327476