Senior Specialist, Senior Archivist

Job Description

Under minimal direction and supervision, the Senior Archivist will facilitate specific archival activities and enables alignment with satellite archives.  This role will be a key contributor to archival activities associated with Nonclinical document and electronic data storage utilizing indexing and retrieval systems in a manner consistent with Good Laboratory Practices (GLPs) and current federal regulations.  The Senior Archivist will support the Chief Archivist as a primary backup during regulatory inspections and will coordinate standard archival operations including the ability to readily determine the status and location of original data / documents, specimens, slides, photographs, and other information in digital form derived from the conduct of related activities within the department (internally) or at contract laboratories (externally).  May also serve as liaison to Archivists at other locations,  and support satellite archive operations as directed by management.

Key Responsbilities:

• Independently supports archival operations as directed by management and/or Chief Archivist, including but not limited to, indexing, filing, retrieval, and electronic archival of study and submission materials as required utilizing demonstrated technical competencies and knowledge within the functional group.  May contribute to the operations of satellite archive(s) and may assume primary responsibility for specific archive functions. 

• Supports the Chief Archivist as primary backup in Quality Assurance audits and regulatory inspection activities.

• Demonstrates comprehensive knowledge and understanding of GLP practices and applies knowledge of GLPs to proactively identify risk and ensure compliance and inspection readiness within scope and role in Archives.  Substantially contributes to the preparation of applicable SOPs and Polices and may serve as author or owner of select SOPs or policies.

• Provides value-added support to customers with archival and provision of study and submission information as needed.  Utilizes appropriate computer systems and tools and works with staff and partners to understand, investigate, and respond to complex information requests.  May serve as system owner for one or more tools.

• Collaborates effectively within a functional group or across groups, may work across projects.  Contributes toward meeting individual and departmental goals.  May have a supporting role in business / operational activities and relationships with partner groups interfacing with Archives.

• May participate in or contribute to educational and training opportunities to further develop technical competence and professional development.

Qualifications:

Education:

• Bachelor's (with 5+ years) or higher education (with 3+ years) in Biological/Chemical sciences, Library Sciences, or related discipline and relevant experience

Required Experience and Skills:

• Scientific or operational experience with nonclinical safety studies
• Ability to identify scientific study content and materials to facilitate archival, gap analysis, issue resolution, indexing and retrieval in computerized systems, and regulatory compliance
• Familiarity with good laboratory practices  
• Demonstrated teamwork and partnering skills, with a background in mentoring, supervising or leading groups
• Skilled at solving basic problems with creative, efficient solutions and able to gather data and respond to new, complex, or problematic situations
• Effectively organizes work efforts and prioritization of tasks; utilizes resources optimally and deliver work products within established and appropriate deadlines.
• Can identify opportunities that add value to the work and to the business; takes advantage of opportunities for change.
• Strong oral and written communication skills commensurate with professional collaboration inside and outside the functional group and department
• Able to analyze and interpret data/information in an objective, thoughtful and efficient manner and apply results to decision making and communicates analyses in terms that can be understood by stakeholders
• Experience with Microsoft office systems

Preferred Experience and Skills:

• Experience working in a GLP environment, with regulated records & computer systems, archival of paper, specimen, and/or electronic records, and scientific / laboratory systems
• Knowledge of Pharmaceutical Discovery, Development and Lifecycle Management: Able to apply knowledge of current and relevant trends to optimize the support of drug discovery, development and lifecycle management processes across key functional groups

#EligibleforERP 

Required Skills:

Archival Management, Bioanalysis, CAPA Management, Cytology, Document Indexing Software, Document Management, Electronic Lab Notebook (ELN), Electronic Records Management (ERM), GLP Regulations, Good Laboratory Practices (GLPs), Method Verification, Microfilming, Pathology, Quality Assurance (QA), Standard Operating Procedure (SOP), Toxicology

Preferred 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:

EEOC Know Your Rights

EEOC GINA Supplement​

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

The salary range for this role is

$106,200.00 - $167,200.00

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:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/15/2026

*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.