Job Description

The Senior Specialist, Quality serves as a member of a team responsible for instituting consistent practices across the Durham facility in the disciplines of Deviation Management, Complaints, Corrective Action/Preventive Action Management, Annual Product Review Authoring, and Quality Council.

The Senior Specialist, Quality Assurance will be primarily responsible leading the Deviation and CAPA management systems. The role is responsible for leading the local community of practice and representing Durham in the global communities of practice associated with the indicated quality systems.

General Profile:

• Monitor standard work within the assigned quality systems and implement improvements to adherence to compliance requirements

• Direct support of regulatory inspections and audits, including presentation/defense of Deviation and CAPA Management systems during regulatory inspections.

• Metrics reporting and development in support of Quality Council

• Lead site Community of Practice (CoP) providing relevant ongoing system updates and facilitate collection of feedback to share within the global CoP.

• Make decisions guided by policies and procedures that impact the unit’s ability to meet performance objectives

• Influence stakeholders across various departments and levels, fostering collaboration and alignment on quality initiatives

• Support of site deviation management huddles, as needed

• Perform SOP development, review, and/or quality approval

• Assist in Permanent Inspection Readiness projects

• Other duties as assigned by Management.

• 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 Educational Requirement and Experience:

• Bachelor’s degree (BA/BS) in Biology, Biochemistry, Chemistry, Engineering or other relevant scientific discipline

• Minimum of five (5) years experience supporting pharmaceutical manufacturing/quality management systems

• Demonstrated ability to independently manage multiple priorities, ensuring timely completion

• Drives results, escalation of issues / concerns to management, as appropriate.

 

Preferred Experience and Skills:

• Technical writing skills

• Quality systems experience

• Pharmaceutical vaccine manufacturing experience

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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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:

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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”.

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Applied Engineering, Applied Engineering, Aseptic Manufacturing, Biochemistry, Chemical Biology, Collective Bargaining, Complaint Management, Compliance Reviews, Consulting, Corrective Action Management, Driving Continuous Improvement, EU GMP, GMP Auditing, GMP Compliance, Immunoassays, Immunochemistry, Inspection Readiness, Job Descriptions, Master Batch Records, Microbiology, Organic Chemistry, Pharmaceutical Manufacturing, Pharmaceutical Systems, Physiology, Policy Compliance {+ 14 more}

 Preferred Skills:

Job Posting End Date:

05/27/2025

*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.