Job Description

Job Description:

Senior Specialist, Quality Assurance

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 for conducting and supporting customer Product Quality Complaint investigations, Adverse Event investigation, and Quality systems metric generation.By providing administrative support, the successful candidate will assist the Director and Associate Director with building and/or improvement of programs by defining requirements established via in depth review of existing Deviation/ Corrective Action and Preventive Action Management and Complaint/Adverse Event Quality Systems, which will be done in concert with strategic direction facilitated by our global business model and regulatory compliance.

General Profile:

• Investigation of Product Quality Complaints and Adverse Events

• Biological Product Deviation Report submissions to FDA associated with Product Quality Complaint, or site Significant Deviations

• Serves as Subject Matter Expert for areas of responsibility

• Direct support of regulatory inspections and audits, including presentation/defense of Complaints/Adverse Events system during regulatory inspections

• Responsible for identification of trends, ongoing monitoring of the system, and providing recommendations for continuous improvement

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

• Coordinate responsibilities between site/functional management, site/functional SMEs

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

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

• Perform data analysis and metrics to ensure quality of the Deviation/ Corrective Action and Preventive Action & Complaint/Adverse Event Management System programs

• Assist in Permanent Inspection Readiness projects

• Other duties as assigned by Management.

• Assist in evaluating existing Deviation, Corrective Action and Preventive Action and Complaint/Adverse Event systems on the global and local level and assist in the implementation of consistent management process across the site

• 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:

• Experience with COVE, Complaints, BPDR

• Experience with APR Authoring

• Technical writing skills

• Quality systems experience

• Pharmaceutical, Vaccine or Biologic manufacturing experience

VETJOBS

EBRG

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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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 if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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

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:

Relocation:

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Travel Requirements:

Flexible Work Arrangements:

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Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe 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:R332207