Sr. Technical Documentation Specialist - Manufacturing/Engineering

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Summary:

The senior technical document specialist is responsible for using technical knowledge/concepts while partnering with manufacturing, maintenance, and engineering teams to create and revise manufacturing, maintenance, and engineering documents including BPRs, SOPs, CCRs, Manufacturing Methods, etc.  The senior technical document specialist will ensure documentations are streamlined, align with the manufacturing, maintenance, and engineering processes/procedures and that they comply with regulatory standards.  They may lead projects and investigations of larger scope (or portions of projects and investigations).  They are often called upon by peers for guidance and collaboration.  They may direct small employee groups’ work or activities.

Primary Responsibilities for Role:

• Must be able to perform all responsibilities listed in summary
• Qualified site document author
• May direct a small group of employees
• Manage the change control process
• Chair meetings including business unit meetings
• Manage weekly packets and documentation in Meridian or equivalent document management system
• Subject matter expert for process equipment and workflow for Manufacturing document (SOPs, BPRs, Qualifications, etc.)
• Subject matter expert for documentation related systems (DCM, SAP, Meridian or equivalent document management system, etc.)
• Performs partial or complete incident investigations, CAPA management, and excursion inspections assigned to business unit
• Performs SAP materials and transaction management
• Performs inventory tracking, discrepancy management, and report reconciliation
• May perform environmental monitoring and reporting
• Serves as a consultant to management within specific area/disciplines (documentation, quality notifications, incident investigations, quality management review, CAPAs, training, environmental monitoring, inventory management and reconciliation)
• Managers and supervisors may assign other duties as needed and required

Knowledge, Skills, Abilities:

Must be able to communicate effectively at all levels.  Must demonstrate strong technical and/or regulatory expertise and ability to adapt to changing circumstances.

Education/Experience:

• BS/BA degree in a relevant field and six years  (6 yrs) of related experience.  An equivalent combination of education and experience may be considered.  In addition he/she must be a SME in 5+ Unit Operations and 2 functions or 2 departments

Unit Operations are defined as:  Aseptic Processing, Filtration, Chromatography, Centrifugation, Lyophilization, Packaging/Labeling, Cleaning, Sterilization, Mixing, Laboratory Technique, Plant Utilities, GMP Utilities, Formulation, Viral Inactivation, Material Handling, Cold Chain Shipping/Distribution.

Functions are defined as:  Investigations, Documentation, Projects, Technical Support, SAP/Bioman/SGP, CIP, Compliance, Scheduling, Logistics, and Inventory Management.

Departments are defined as:  Clarification, Fractionation, IGIV, Purification, Filling/Packaging, Site Engineering, Technology, Quality Operations, Supply Chain.

Work is performed in an office environment with exposure to electrical office equipment. May occasionally enter BioRisk Area.   Exposure to biological fluids with potential exposure to infectious organisms. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists.   Occasionally walks and stands. Occasionally bends and twists neck.  Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Drives: varies may or may be required to frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences.  Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.

This job description is intended to present the general content and requirements for the performance of this job.  The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.  Managers and supervisors may assign other duties as needed.

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law.  We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton 

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