Sops And Training Senior Specialist

Senior Specialist SOPs & Training Management

The PDMB Regulated Bioanalytics Department is seeking a Senior Specialist SOPs & Training Management to join our Integrated Logistics & Sample Management group located at our company's state-of-the-art AdVAnce research facility in West Point, PA. At this new facility, we will combine the power of innovative robotics, IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated bioanalytical data. A combination of molecular (e.g., PCR), serology (e.g., ligand binding titer immunoassays), and cell-based assays (e.g., neutralizing assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be fully constructed and ready for occupancy until 2026, initial roles will complete training and perform work primarily at our company's Springhouse Innovation Park facility in Lower Gwynedd Township, PA.

Support Regulated BA organization through management of standard operating procedures (SOPs), and training documentation, ensuring staff have the tools and skills to perform job requirements

Education Minimum Requirement

• BA/BS with 7 years of experience, MA/MS with 3 years of experience, or Ph.D. Degrees may be in a variety of areas, including the biological sciences, computer sciences, medical technology, business management, etc.

Responsibilities

• Strong knowledge of document or training management systems. May also be involved in related new system releases or existing system updates/enhancements
• Creates, updates, and maintains SOPs, training documents, and departmental supporting documents
• Coordinates training assignments, curricula, and administration of our company training management systems
• Operates according to SOPs and safety principles
• Ensures SOP compliance (e.g., periodic reviews, revisions, and establishment of new SOPs)
• Demonstrates good documentation practices (GDP) in all forms of documentation
• Plans, tracks, and ensures all aspects of SOPs & Training deliverables are progressing according to specifications and timelines
• Communicates SOP and training information across various functional areas, support functions, and alliance partners
• Follow issues through to resolution and ensure all key stakeholders are informed of outcomes
• Builds and maintains relationships with cross functional stakeholders
• Builds out training curriculum across the PDMB organization providing staff the tools and skills to perform job requirements
• May participate on project or process improvement teams to drive enhancements

Required Experience & Skills

• Strong written and verbal communication skills
• Strong organization skills and attention to detail
• Ability to perform under pressure and in a changing environment
• Operates under minimal supervision to perform general tasks (e.g., data input and output)
• Ability to establish good working relationships and engage across functional teams
• Ability to hold others accountable for delivery

The salary range for this role is $104,200.00 - $163,900.00. 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.