Technical Writer/Document Writer

Description

100% onsite is required
work schedule: Normal business hours

Job Summary:
The GMP Facilities Document Specialist is responsible to manage the documents created by the GMP Document Facilities Department to ensure that the documents are tracked and organized through the document lifecycle

Duties/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 with 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.

Document Specialist 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 arenrequired.
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 Specialist 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 LMS (learning management system) Manager.
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. Individuals printing or viewing a controlled document from a source other than the Electronic Document Management System are responsible for ensuring that they are printing or viewing the current version.
Filing of equipment asset documentation and routine and on demand work
orders.

Other Additional Responsibilities
Track GMP Facility Department QMS (Quality Management System) actions and provide status updates.
Assist in creation and completion of QMS actions.
Review completion of work orders in CMMS (computerized maintenance management system)
Execute change requests in CMMS.


Education: Required associate s degree, Preferred bachelor s degree in science/engineering

Qualifications
Be proficient in cGMP guidelines for documentation management in accordance with company policy and procedures.
Complete and review documentation 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
Minimum 1-2 years document management experience.
Pharmaceutical industry preferred.