Specialist, Quality Assurance - Records Management at Merck

Job Description:

Skills)

Job Description In Primary Posting Language (Include Requirements For Education, Experience And Skills)

The Records Management e-Data Specialist is a member of the Records Management Center of Excellence (RM CoE) responsible for the archival and lifecycle management of electronic records. This role ensures RM CoE-owned archived data — housed in repositories such as AWS S3, file shares, and Share Point — is organized, maintained, and accessible in line with policy and service commitments.

Key responsibilities

• Perform annual reviews and clean-up of electronic archived records across RM CoE repositories to maintain accuracy, integrity, and compliance.

• Support archived data retrieval requests from business partners and stakeholders, delivering requested information within agreed service-level targets and assisting with audit requests as required.

• Maintain and monitor RM CoE-owned electronic repositories (AWS S3, file shares, Share Point), including ongoing access control administration, routine health checks, and periodic retrieval testing.

• Contribute to data migration, decommissioning, retirement, and archival projects, coordinating with internal teams and external partners to ensure compliant and value-driven outcomes.

• Support administrative functions tied to RM CoE repositories such as documentation, change control, and configuration tracking.

• Produce and maintain project reporting, dashboards, and status updates to keep stakeholders informed of repository health and activity.

Education, Skills & Experience: Qualifications:

• Bachelor's Degree in Life Sciences, Engineering or related relevant discipline

• Minimum of 8+ years’ experience in the pharmaceutical environment or another regulated industry

• Capable of working and communicating effectively with cross-functional and cross-divisional partners

• Strong communicator with excellent verbal and written skills; ability to communicate effectively with global audiences

Required Experience and Skills:

• Experience with reporting tools or analytics using Power BI, Share Point, Excel, etc.

• Experience in computer systems validations and equipment qualifications

• Experience in document control management with GDP (Good Documentation Practices)

• Ability to follow written procedures, SOPs, and change control processes

• Self-motivated with a high degree of ownership and accountability for results

• Ability to prioritize time and problem solve to focus on the most impactful activities / initiatives

• Tracks, secures, and controls e-data archived inventories and are accountable for timely processing of records retrieval requests.

Preferred Experience and Skills:

• Experience with any content management, digital validation platforms, inventory management systems (Veeva, ECM, Kneat-e Val)

• Experience supporting audits

• Familiarity with regulatory requirements relevant to the industry (e.g. FDA, ICH, SOX, GDPR)

• Multi-Language preferred

• The ability to work in ambiguity, to problem solve, and to make rapid / disciplined decisions

• The ability to work with diverse personalities and to collaborate with global functions, global Co Es, and strategic partners

• Optimistic and positive when faced with adversity

• Continually evaluates RM Operational processes and effectiveness and implements continuous improvements where necessary

• The ability to take on greater responsibility in the organization overtime.

Required Skills:

Access Control Management, Access Control Management, Adaptability, Applied Engineering, Aseptic Manufacturing, cGMP Compliance, Content Management, Content Management Systems (CMS), Data Analysis, Decision Making, Documentation Review, Electronic Records, FDA Regulations, Interpersonal Relationships, Inventory Control System, Inventory Management, Laboratory Operations, Laboratory Quality Control, Mechatronics, Pharmaceutical Management, Problem Solving, Quality Inspections, Quality Operations, Regulatory Compliance, Regulatory Inspections {+ 2 more}

Preferred Skills:

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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: VISA Sponsorship:Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift: Valid Driving License:Hazardous Material(s):

Job Posting End Date:

05/14/2026

**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.