Job Description

Senior Specialist Quality Assurance

Senior Specialist, Quality Systems and Compliance (P3)

Our company is expanding its global recombinant vaccine production network by investing and adding a 225,000-square-foot building within the footprint of the Maurice R. Hilleman Center for Vaccine Manufacturing in Durham, NC. The new facility will be used to produce the bulk active ingredient for the vaccine, comprised of fermentation, microfiltration/ultrafiltration, and chromatography steps.

The Quality Senior Specialist provides expertise in the coordination of resources and equipment pertaining to qualification/validation activities supporting the vaccine expansion facility.

Primary Responsibilities:

The Quality Senior Specialist will be responsible for comprehensive management of all activities required to successfully support Process Performance Qualification (PPQ) and routine manufacturing to include the following:

• Ability to work independently and as a member of a team.

• Manages individual contributors (professional employees), as applicable.

• Contributes to the performance and results of the expansion project.

• Adapts plans and priorities to address resource and operational challenges.

• Decisions are guided by policies, procedures and/or business plans.

• Provides technical guidance to employees, colleagues, or clients.

• Anticipates and interprets client and/or customer needs to identify solutions.

• Ability to provide off shift and weekend support during critical processing and manufacturing.

• Responsible for daily support and oversight of all production processes to ensure compliance with regulatory requirements as well as policies and procedures.

• Responsible for establishing processes that ensure required safety guidelines are followed.

• Review and approve qualification/validation documents for equipment and process (i.e., IQ/OQ/PQ).

• Review and approve Performance Qualification documents pertaining to environmental monitoring and process qualification.

• Provides Quality input, direction, and approval of Quality Notifications (QNs) and Change Requests (CRs). Author, review, and approve SOPs.

• Assume project management opportunities, by leading and participating in process improvement, learning events, or business support initiatives, as guided or approved by Quality management.

• Train employees on new or revised processes or procedures.

• Review and approve BOM changes and Master Batch Records.

• Review and approve Operations, Technology, or Automation protocols.

• Leads or actively participates in project suite teams, as required.

• Direct support of regulatory inspections and audits.

• Direct support of validation activities and all other associated Quality functions.

• Other duties as requested by Management.

• Independently supports resolution of technical and operational problems through collaboration with peers.

• Applies appropriate risk management while adhering to cGMP requirements.

• Makes decisions guided by policies and procedures that impact the team's ability to meet performance objectives.

• Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes.

Minimum Education Requirement and Experience:

• Bachelor's degree (BA/BS) in Biology, Biochemistry, Chemistry, or other relevant discipline with a minimum of five (5) years' experience supporting the pharmaceutical manufacturing industry, specifically in pharmaceutical operations, technical operations, validation and/or process Quality Assurance.

Required Experience and Skills:

• Strong Batch Record Review and Release experience in electronic systems

• Previous investigation and CAPA experience, Batch Record Review, Validation IQ, OQ, PQ, Change Control.

• Has in-depth knowledge of cGMPs and domestic and international regulatory requirements.

• Is expected to possess a high degree of problem-solving ability.

• Must have demonstrated ability to independently manage multiple high level/ priority projects, ensuring timely completion.

Preferred Experience and Skills:

• Quality Technical experience

• Electronic Batch Records (MES)

• cGMP experience in a sterile, bulk or finished pharmaceutical environment.

• Product, Raw Materials and Components Release

• Experience with SAP, MRP/ERP systems and/or GLIMS

• Flexibility to support on-call off shift and hyper-care activities.

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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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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

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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:R323932