Responsibilities

Job Responsibilities:

• Coordinate the creation, review, approval, and archiving of SOPs within Veeva Vault for the R&D department.

• Maintain version control and track document changes to ensure accuracy and compliance with R&D standards.
• Ensure all documentation aligns with internal quality standards and is audit-ready.
• Collaborate with the LMS team to ensure that R&D training materials are updated and accessible to all relevant personnel.
• Manage the integration of SOP-related training within the LMS to facilitate compliance and employee education.
• Ensure that training completions are tracked and recorded accurately within the LMS.
• Work closely with cross-functional teams, including R&D Quality Assurance, R&D Operations, and Human Resources, to ensure effective SOP implementation.
• Serve as a liaison between R&D document management and LMS teams to streamline processes and communication.
• Identify opportunities for improving documentation processes and workflows within Veeva Vault and LMS.
• Participate in the development and implementation of best practices for document and LMS management in R&D.
• Provide training and support to R&D teams on document management processes, Veeva Vault, and LMS functionalities.
• Serve as the point of contact for troubleshooting and resolving issues related to Veeva Vault and LMS in R&D.
• Conduct regular audits of Veeva Vault and LMS records to ensure all documents and training completions are up-to-date and compliant with R&D quality standards.
• Prepare and present reports on document status and compliance metrics to R&D management.
• Issue unique report numbers for final research documents and upload them to the archival system, ensuring that all metadata is accurately recorded and compliant with organizational standards for ease of future retrieval and reference.
• Oversee the issuance, tracking, storage, and archival of lab notebooks and binders.
• Ensure each item is uniquely numbered and logged in the tracking system.
• Maintain organized storage conditions and facilitate the secure archival of completed materials to support regulatory compliance and future reference needs.
• Facilitate the Corrective and Preventive Action (CAPA) process workflow by assisting in the identification, documentation, and analysis of issues.
• Support the execution of corrective actions and verification of their effectiveness.
• Collaborate with cross-functional teams to ensure smooth workflow operations in compliance with quality standards and regulatory requirements, while maintaining comprehensive records of CAPA activities to aid in audit readiness.

• Maintain training and compliance in areas of health and safety, security, environmental and operational aspects of daily activities in the working environment.

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities of this job at any time.

Critical Skills:

• Must have a strong command of Microsoft Office Word, Excel, Veeva Vault, Learning Management System (LMS) and Adobe Acrobat
• Writing skills are very important as they will be documenting complex aspects of the system
• Strong interpersonal skills and demonstrated ability work independently
• Organized and task oriented
• Excellent written and oral communication skills - especially on technical topics
• Self-directed and motivated individual who is able to operate in a rapidly changing business environment
• Customer-oriented, conducting job function with a primary focus on customer satisfaction (internal & external) and ability to deal with customer complaints
• Ability to Build consensus among team of stakeholders
• Excellent critical thinking/analytical and problem solving skills

Basic Qualifications:

• Bachelor's degree in Computer Science or Life Science with 2+ years of relevant technical experience OR

• Associate's degree in Computer Science or Life Science with 4+ years of relevant technical experience OR
• High School Degree/GED with 10+ years of relevant technical experience

Preferred Qualifications:

• At least 2-4 years of working in pharmaceutical R&D related experience
• Good knowledge of GMPs, 21CFR Part 11, USP 1058 - and other relevant industry regulations and guidance
• Experience with Technical Writing - Preferably Standard Operating Procedures or Validation documents.
• Experience with scientific/manufacturing instrumentation/equipment
• Experience with manufacturing environments and/or working in and with GMP regulated environments and systems
• Experience with IT systems management and associated processes
• Any special qualification in GxP, CSV domain, ALCOA will be beneficial

Working Environment:

• Must be able to work in a laboratory, controlled environments requiring personal protective equipment (e.g., lab coat, safety glasses, etc.) in laboratory.
• Job pace may be fast and job completion demands may be high.
• Must be able to remain in a stationary position more than 25% of the time
• The person needs to occasionally move between labs, corridors, adjoining rooms, and buildings onsite Frequently operate on instruments, objects, tools or controls, which will require regularly bending, squatting, stretching and reaching in order to perform in a service function.
• Occasionally move or lift up to 25 pounds (potential for occasional lifting of up to 50 pounds).
• Specific vision abilities required by this position include without limitation, the ability to observe details at close range distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus in order to perform the essential service functions of this position.
• Occasionally operates a computer and other office machinery, such as a calculator, copy machine, and computer printer.
• Employee may be required to handle hazardous waste according to local, state, and federal regulations. Duties may include identifying, handling, generating, accumulating, storing and labeling hazardous waste.
• Potential risk to lab-based hazards including but not limited to extreme temperature, biological materials, and hazardous chemicals.
• May be required to complete Medical Clearance, Respiratory Protection Training, and Fit Testing to wear a respirator as protection against hazards present in the laboratory environment.

The annualcompensation range for this full-time position is $67,600.00 to $84,000.00. The final base pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.