Senior Specialist, Senior Archivist

Merck • Upper Gwynedd Township, PA

10h • Hybrid

About The Position

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.

Requirements

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

Nice To Haves

• 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

Responsibilities

• 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.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Senior