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

Grifols is a global healthcare company whose mission is to improve the health and well-being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.

We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.

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. Also may be required to train others in his/her area of expertise and other duties as assigned.

Primary responsibilities for role:

Write new procedures (i.e. batch production records, standard operating procedures, etc.) regarding manufacturing process.

May consult with Engineering, Validation, Quality Operations, and/or Technology regarding manufacturing concerns, incidents, or discrepancies.

Consult with technicians to ensure ease of read and understanding of documents, procedures, etc.

Collaborate with trainers to ensure clarity in regards to document revision training.

Facilitate training on document revisions and use Repo and Access databases to track documents.

Ensure correct revisions and documents are available when needed while also tracking all documents and their workflow.

Provide assistance in locating requested documents needed for investigations and may serve as a subject matter expert (SME) during investigations.

Maintain new logbooks each year by reviewing to ensure documents are signed off and complete.

Review documents during audit and store in archives was complete. May be sought for counsel within field of expertise.

Makes decisions with designated assignments that influence the goals of the department.

Knowledge, skills & abilities:

Must be able to communicates 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 he/she must be a 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.

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:

Makes independent decisions within defined areas of responsibility.

Serves as a consultant to management within a specified area/discipline.

Advances technical project proposals to senior management, following through to successful completion.

Influences commitment of resources at divisional/departmental level.

Lead intradepartmental teams.

Develop realistic/accurate weekly production schedules .

Coordinate manufacturing schedule with other business units.

Schedule manufacturing equipment utilization.

May schedule calibrations, maintenance, project activities, validation activities

SME for process equipment & workflow and for document corrections & notes to batch production records (BPRs).

May supervise a small group of employees.

Knowledge, skills & abilities:

Must be able to communicates 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 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, 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 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.

EEO/Minorities/Females/Disability/Veterans

CLK789

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

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

Req ID: 78116

Type: Regular Full-Time

Job Category: Manufacturing