Facilities Specialist

$30-$36 Hourly 

Description: 
Manage the documents created by the GMP Facilities Department to ensure that the documents are tracked and organized through the document lifecycle.
Respond to Customer requests in a professional and timely manner.
Respond in accordance to cGMP policies and procedures.
Train colleagues 
Work with internal and external partners. Provide cGMP oversight of GMP documentation to ensure they are operating within the cGMP policies and procedures.
Demonstrates and promotes Values and behaviors.
Preparation and distribution of SOPs/WPs for signatures within electronic document management system; 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
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.
Filing of equipment asset documentation and routine and demand work orders.
Complete and review documentation work orders to ensure cGMP good documentation practices and change control procedures are being followed

Qualifications: 
AA / AS degree or acceptable trade certification from technical
Minimum 3 years document management experience
Minimum 3 years in the Pharmaceutical industry preferred
GMP document review and maintenance experience
Proficient in cGMP guidelines for documentation management in accordance with company policy and procedures
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
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
Ability to work a minimum of a 40 hours work week
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 procedures
 

*******EQUAL OPPORTUNITY EMPLOYER******

*****COMPENSATION IS COMMISERATE WITH EXPERIENCE*****