Job Description

Our Company has expanded its global recombinant human papillomavirus (HPV) vaccine production network by investing $650 million 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 is used to produce the bulk active ingredient for the HPV vaccine, comprised of fermentation, microfiltration/ultrafiltration, and chromatography steps.

Approximately 614,000 people are diagnosed with certain HPV-related cancers each year. Our Company manufactures the two HPV vaccines that are predominantly utilized to eradicate these cancers globally. In recent years, countries around the world have enacted new or expanded HPV vaccination programs, which has created an unprecedented increase in global demand. The manufacturing facility in Durham plays a critical role in the network of plants that produce life-saving medicines and vaccines, including our HPV vaccines.

Description

The Quality Associate Specialist provides guidance/direction on the shop floor during processing and subsequent record reviews supporting the HPV facility working night shift which includes weekend coverage.

GENERAL PROFILE:

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

• Contributes to the performance and results of the site.

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

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

• Provides quality and compliance guidance to employees, colleagues or clients.

FUNCTIONAL EXPERTISE:

The Associate Quality Specialist will be responsible for comprehensive management of all activities required to successfully support manufacturing include the following:

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

• Responsible for ensuring required safety guidelines are followed.

• Review and approval of electronic batch records and associated documents

• Review and approve documents pertaining to environmental monitoring and SOPs

• Participates 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 automation interventions.

• Actively participates in project suite teams, as required.

Other:

• Direct support of regulatory inspections and audits.

• Other duties as requested by Management.

PROBLEM SOLVING:

• 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.

QUALIFICATIONS:

Required:

• Bachelors or Masters Degree in Biology, Biochemistry, Chemistry or other relevant discipline.

• Minimum of 1 year experience in pharmaceutical operations, technical services, and/or quality operations.

• Ability to work night shift including weekend coverage

• Demonstrates flexibility and ability to manage multiple priorities.

• Demonstrates interpersonal, technical aptitude and problem-solving skills.

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Current Employees apply HERE

Current Contingent Workers apply HERE

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.

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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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

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”.

The salary range for this role is

$70,500.00 - $110,900.00

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:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

3rd - Night

Valid Driving License:

No

Hazardous Material(s):

N/A

Required Skills:

cGMP Compliance, Decision Making, General Safety, Good Manufacturing Practices (GMP), Manufacturing Support, Policy Procedures, Quality Assurance (QA), Quality Support, Social Collaboration, Working Independently

Preferred Skills:

Production Operations

Job Posting End Date:

06/27/2025

*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.

Requisition ID:R353146