Documentation Specialist

Hours Worked: Typically, Monday through Friday, forty-hours per week.

However, must be flexible to meet the needs of the department and complete other projects as assigned.

Position Summary:

The Documentation Specialist is responsible for supporting the objectives of the client Compliance Team at their production site.  The Documentation Specialist will manage and organize Quality Documentation required by the client. This will include issuing, maintaining, controlling, and auditing documentation required for Quality and cGMP compliance, under the guidance of the client Compliance Team Lead.

Duties include Batch Record Review and gathering/reviewing documents for product release, managing Quality documentation, digitizing paper batch records and completing plant-wide quality reviews using two different client LIMS systems.

Duties and Responsibilities:

It is everyone’s responsibility to live out our Values and Absolutes

by Shaping a World of Trust while ensuring responsible progress.

• Manages, files, and updates document archives for Quality related documents according to company policy
• Responsible for the review, filing, and maintenance of master batch records and associated documents used to support product releases, such as electronic quality inspection documents
• Assists with and/or performs daily releases of finish product batches to meet Positive Release Time KPI objectives
• Collaborates with cross functional teams to drive timely releases
• Coordinates with distribution centers and/or quality engineers to manage blocked inventory
• Assists with the creation and distribution of COAs for exports
• Provides supporting documentation required for product registration in various countries
• Supports the maintenance of training documents as needed
• Participates in Internal and External Audits including Mock Recovery and Recall Exercises
• Manages signature files and CV documentation for the site
• Participates in projects to drive Continuous Improvement initiatives

• Follow the guidelines set forth with clients and in the company Quality, Health, Safety, Security and Environmental policies and procedures.
• Comply with company and client management systems in accordance with appropriate regulatory agencies.
• Follow the guidelines set forth by company and client Quality Manual and Safety / Chemical Hygiene Plan.
• Other duties as defined by manager, department needs and workload.

Skills & Proficiencies:

• High level of proficiency with Google suite (Docs, Sheets, Slides, etc)

• Excellent written and oral communication skills, including technical writing
• Excellent organization skills
• Ability to perform multiple tasks
• Ability to organize and prioritize workload to meet or exceed deadlines
• Individual and Team work ethic
• Proficiency with Windows, Word & Excel
• Attention to detail
• Positive attitude, self-motivated, high level of engagement
• Adheres to company values

Education and Experience:

• Degree requirement: Associate's Degree in Applied Science or closely related field
• Minimum of 1 year experience in a Quality role, though previous experience in a Manufacturing setting, preferred.

An equivalent combination of education and experience may be accepted in lieu of above.