Job Description

Senior Specialist, Quality Technical (P3)

The Senior Specialist Quality Technical role is responsible for supporting deviation management, change control, site qualification/validation, equipment qualification, and technical quality support for sterile manufacturing of vaccines. The ideal candidate would have knowledge of the referenced areas of responsibility as well as a thorough understanding of sterile manufacturing and background working with grade A,B, C and D area including isolator operation.

Primary Responsibilities:

The Quality Senior Specialist will be responsible for providing quality oversight and technical guidance of sterile vaccine manufacturing activities across the Durham VMF IPT. Areas of responsibility will include the following:

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

• Contributes to the performance and results of the daily manufacturing activities.

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

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

• 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), Corrective/Preventative Actions (CAPAs) and Change Requests (CRs).

• Author, review, and approve SOPs.

• Review and approve BOM changes and Master Batch Records.

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

• 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.

• 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.

• 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.

• Provides support for technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units.

• 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.

• Other duties as requested by Management.

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:

• 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 or MRP/ERP systems

• Experience with SAP, or GLIMS

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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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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:

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:R326319