Specialist, Quality

Job Description

Specialist, Quality

Position Overview

The Specialist (Stability Coordinator) is an individual contributor role focuses on supporting global External Entities (EE) release and stability program operations. Responsibilities include ensuring compliance in testing and storage of company products. The role reports to the GQSS External Testing Hub lead Associate Director and collaborates with team members, including Associate Director (P4) and Senior Specialist (P3).

Essential Functions and Responsibilities (Includes, but are not limited to)

The Specialist, is responsible for:

·       Compile and analyze stability data for integrated product stability programs.

·       Prepare stability-related regulatory documents and conduct annual reviews.

·       Review batch-specific protocols (BSP) for compliance and accuracy.

·       Author Annual Stability Reports and stability sections of Annual Product Reports.

·       Act as a change owner/initiator by managing change control activities to enhance stability program operations.

·       Provide 100% second-person review support to ensure document accuracy and compliance.

·       Assist in creating and updating training materials for system changes.

·       Complete defined technical assignments independently.

·       Utilize LIMS, MS Word, Excel, and statistical platforms (e.g., JMP, Spotfire) effectively.

·       Support internal and customer audits at EE.

·       Manage year schedules, maintain SDS or future trackers, chase forms, and ensure sample delivery to External Entities (EE).

Education: Bachelor’s degree in a science-related or computer science field.

Required Experience and Skills:

• Minimum of 2 years of relevant experience in the pharmaceutical and/or biotechnology industry, with knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP and regulatory requirements.

• Proficient in English, both verbal and written.

• Ability to participate effectively in cross functional teams.

Preferred Experience and Skills:

·       Experience with compliant industry platforms/systems (e.g., SAP, TrackWise, electronic document management systems, change control systems).

·       Proficient with LIMS/Labware v8, Microsoft Excel, and statistical programs.

Required Skills:

Preferred Skills:

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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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