Grifols Shared Services North America, Inc Technical Document Specialist II/Sr in Clayton, North Carolina

For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.

Overview:

The Technical Document Specialist II/Sr. Technical Document Specialist - Label Development provides label development support to create new and revised labeling to meet market timelines. Customers include Regulatory Agencies, Regulatory Affairs, Manufacturing, Marketing and/or external customers.

Technical Document Specialist, TECH II:

The Technical Document Specialist II is responsible for using professional concepts as well as company policies and procedures to resolve a wide range of complex manufacturing concerns. He/she will be held accountable for independent decision making and must possess the ability to change priorities based on the business needs. The incumbent will develop alternative solutions to problems, handle complex problems independently and demonstrate consistent application of technical knowledge and/or regulatory knowledge. This position will be responsible for executing assignments of medium complexity, developing solutions for defined problems by communicating effectively at all levels. The incumbent may also be required to train others in his/her area of expertise and perform other duties as assigned.

Primary responsibilities for role:

  • Coordinate the creation/revision of labeling components with external typesetters, review typeset copies, obtain appropriate approvals, approve vendor print proofs and work with Supply Chain to establish effectivity dates.

  • Proofread labeling components and review documentation for completeness and accuracy.

  • Communicate effectively with external vendors, including typesetters and print vendors.

  • Program and maintain internal Label Development electronic files using Microsoft Excel, EasyLabel, Open Site Master and Kirk-Rudy Xjet software. This includes all shipper, pallet, export, supplemental and barcode print files that are developed and approved internally.

  • Coordinate Change Controls and SAP requests for revisions to labeling.

  • Coordinate write off requests for obsolete labeling.

  • Maintain labeling files on the Portal and with external marketing firms and coordinating revisions and effectivity dates to ensure customers have access to the most recent label content.

  • Perform other duties as 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.

Requirements:

BS/BA degree in a relevant field and 4 years of related experience. An equivalent combination of education and experience may be considered. In addition, preferred SME in 2-4 Unit Operations and 1-2 functions or 1-2 departments.

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

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

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

Technical Document Specialist SENIOR:

The Sr. Technical Documentation Specialist is an established, technically competent professional who independently develops and implements solutions for various manufacturing concerns. He/she leads projects of larger scope (or portions of projects) and is often called upon by peers for guidance. He/she coaches and/or facilitates training for other employees. He/she may supervise employees which also involves managing employee relations matters and conducting performance management reviews. Due to the versatility of this employee's background and competencies, other duties may also be assigned.

Primary responsibilities for role:

  • Coordinate the creation/revision of labeling components with external typesetters, review typeset copies, obtain appropriate approvals, approve vendor print proofs and work with Supply Chain to establish effectivity dates.

  • Proofread labeling components and review documentation for completeness and accuracy.

  • Communicate effectively with external vendors, including typesetters and print vendors.

  • Program and maintain internal Label Development electronic files using Microsoft Excel, EasyLabel, Open Site Master and Kirk-Rudy Xjet software. This includes all shipper, pallet, export, supplemental and barcode print files that are developed and approved internally.

  • Coordinate Change Controls and SAP requests for revisions to labeling.

  • Coordinate write off requests for obsolete labeling.

  • Maintain labeling files on the Portal and with external marketing firms and coordinating revisions and effectivity dates to ensure customers have access to the most recent label content.

  • Sr. Technical Documentation Specialist will oversee larger labeling projects and/or coordinate overlapping projects.

  • Perform other duties as 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.

Requirements:

  • BS/BA degree in a relevant field and 6 years of related experience. An equivalent combination of education and experience may be considered. In addition preferred experience as 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, and Viral Inactivation.

  • Functions are defined as: Investigations, Documentation, Projects, Technical Support, SAP/Bioman, CIP, Compliance, and Scheduling.

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

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 drive 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.

EEO/Minorities/Females/Disability/Veterans

Location: [[mfield6]] : [[cust_building]]

Learn more about Grifols at http://www.grifols.com/es/web/international/home

Req ID: 72112

Type: Regular Full-Time

Job Category: Manufacturing