1. PURPOSE AND SCOPE OF POSITION:
The Facilities Specialist is responsible to manage the documents created by the GMP Facilities Department to ensure that the documents are tracked and organized through the document lifecycle.
2. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
•Be proficient in cGMP guidelines for documentation management in accordance with company policy and procedures.
•Complete and review documentation work orders to ensure cGMP good documentation practices and change control procedures are being followed.
•Expert written and verbal communication skills.
•Outstanding customer service skills.
•High proficiency in Microsoft Word, Excel and Outlook.
•Ability to meet schedules and timelines.
•Strong interpersonal skills.
3. DUTIES AND RESPONSIBILITIES
General Roles
Working under minimal direction and guidance and be self-motivated, responsibilities shall include but not be limited to the following;
•Respond to Customer requests in a professional and timely manner.
•Respond in accordance to cGMP policies and procedures.
•Train colleagues as necessary.
•Work with internal and external partners. Provide cGMP oversight of GMP documentation to ensure they are operating within the cGMP policies and procedures.
•Other duties as assigned.
•Demonstrates and promotes Values and behaviors.
Document Coordinator Technical Requirements
•Must have strong organization skills, be a team player and be willing to work in an environment where individual initiative and accountability to projects are required.
•Must be able to work with limited day-to-day supervision.
•Must have a general knowledge of SOP standards.
•Must have experience with record retention, archival processes.
•Must have experience with electronic document management systems.
•Strong PC skills to include: Microsoft Excel and Word Excellent written and oral communication skills.
Document Coordinator Technical Administrative Requirements
•Preparation and distribution of SOPs/WPs for signatures within electronic document management system; as well as organizing, tracking status and timelines
•Assist in creating new procedures and providing input on existing for periodic reviews
•Support GMP Facilities SOP/WP Administration operations, including individual projects and assignments, as needed.
•Format technical document according to standard formatting and update of documents to incorporate Subject Matter Expert review comments.
•Preparation of SOP/WP and supporting documents for submission to the Compliance Wire (training management system) Manager.
•Track GMP Facility Department Quality Management System actions and provide status updates.
•Assist in completing Instrument Data Forms to input new or revise instrumentation
•Assist in criticality assessments
•Responsible for maintenance of Excel spreadsheets for maintenance and tracking of SOPs/WPs.
•Other responsibilities will include filing of equipment asset documentation and routine and demand work orders.
4. EDUCATION AND EXPERIENCE
AA / AS degree or acceptable trade certification from technical
•Minimum 3 years document management experience.
•Minimum 3 years in the Pharmaceutical industry preferred.
5. WORKING CONDITIONS:
A. PHYSICAL /MENTAL DEMANDS:
•Ability to work a minimum of a 40 hours work week.
•Ability to sit, stand and move within workspace for extended periods.
B. ENVIRONMENTAL CONDITIONS:
•Environment may include working at heights, in cold temperatures, and/or constricted spaces
•Ability to work safely when working alone or working with others.
•Ability to work within a GMP environment and properly gown according to room classifications and