Information and Records Management Associate (Part Time)

The Remote Information and Records Management Associate (IRMA) supports the development of records management tools, systems, policies and practices. The IRMA is responsible for day-to-day management of quality records and for managing GxP regulated records, unregulated records, and records maintained within the electronic Trial Master File as well as cataloging, filing and organizing records to allow expedient access and retrieval.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Records and Access Management

• Supports the development of records management policies and practices
• Supports the development of processes, tools and systems for the management of records
• Supports the day-to-day management of quality records
• Conducts an inventory to catalog, categorize, and organize records to allow expedient access and retrieval
• Perform quality assurance audits to confirm adherence to records and information policies, procedure, and controls
• Collaborate with regulated and non-regulated departments to define business needs for records management and establish "source of truth" repositories based on record types
• Supports the development of best practices for external collaboration and exchange of information
• Participate in process improvement to increase record control and accessibility
• Support the development of training related to the management of records and information security
• Manages the archive vendors
• Manages the archival and indexing of studies and project records

Computerized System Management

• Assists in the development, validation, implementation, and management of GxP regulated computerized system (system of records e.g., eQMS, eTMF, LMS, eSignature system)
• Assumes responsibility as system administrator for regulated and unregulated computerized system
• Develops or supports the development of computerized system procedures

Onboarding and Training

• Supports and administers onboarding and training program

• Supports the development and management of training curricula

• Supports the development and management of the company job description and the maintenance of resumes.

• Monitors training compliance,

Vendor Oversight

• Assists in the development and execution of vendor pre-qualification efforts

• Assists with audit preparation and request during qualification audits

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

• Bachelor's degree in Information Science, Library or other related subjects
• 5 years of regulated work experience in data or records management or quality can replace the requirement for a bachelor's degree
• 1-3 years of experience with records management or library expertise, preferred experience in pharma regulated industry.

KNOWLEDGE, SKILLS & ABILITIES

• Ability to work and troubleshoot problems independently
• Detail-oriented and organized
• Excellent verbal and written communication and interpersonal skills
• Proven ability to act in a professional manner in a fast-paced environment, as a representative of the document control function
• Ability to meet deadlines and project deliverables on time

Hours: Part time 20 hours per week. Flexible working hours. Potential for full time (40 hours/week) down the road.

Location: Company is based out of Seattle, WA, but you can be employed in any state, working remotely.