Spclst, Quality Assurance

Job Description

Specialist, Quality Systems and Compliance (P2)- Night Shift

Our company is expanding 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 will be 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's 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 will play a critical role in the network of plants that produce life-saving medicines and vaccines, including our HPV vaccines.

The Quality Specialist provides guidance/direction of resources and equipment pertaining to qualification/validation and start up activities supporting the HPV expansion facility working night shift including weekend coverage Sunday to Wednesday (5:30 pm -4:00 am).

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GENERAL PROFILE:

• 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.

FUNCTIONAL EXPERTISE:

The Quality Specialist will be responsible for comprehensive management of all activities required to successfully support construction, qualification and validation to 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 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 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 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.
• Actively participates in project suite teams, as required.

Other:

• Direct support of regulatory inspections and audits.
• Direct support of validation activities and all other associated Quality functions.
• 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 2 years 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.

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".

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:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
2nd - Evening

Valid Driving License:
No

Hazardous Material(s):
N/A

Job Posting End Date:
05/14/2025
*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:R346773