Supply Chain Documentation Specialist

Grifols
Published
October 5, 2021
Location
8368 U.S. Highway 70 West
Category
Job Type
Base Salary
Competitive base rate based on experience. Benefits including Health, Dental & Vision insurance, 401k with match & immediate vesting, tuition reimbursement.
Job Hours
1st Shift
Experience
Minimum 4 years relevant work expeirence in a cGMP role & 2 years cGMP documentation
Education Requirements
Bachelor's degree in Business, Science or related field.

Description

For more info & to apply: Supply Chain Documentation Specialist

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions. 

Summary:

The Supply Chain Documentation Specialist:

The Supply Chain Documentation Specialist is responsible for using professional concepts as well as company policies and procedures to manage a wide range of Planning and Procurement documentation requirements directly related to product supply.  He/she will be held accountable for independent decision making and must possess the ability to change priorities based on changing business needs while balancing multiple assignments, often with conflicting timelines. The incumbent will develop alternative solutions to problems, handle complex problems independently and demonstrate consistent application of technical and/or regulatory knowledge. This position will be responsible for executing assignments of medium complexity independently and developing solutions for defined problems by communicating effectively at all levels. The Planning Documentation Specialist must be able to analyze, communicate, negotiate, and initiate discussions regarding complex situations in order to support company success. Also, may be required to train others in his/her area of expertise and perform other duties as assigned. 

 

The Sr. Supply Chain Documentation Specialist:

The Sr. Supply Chain Documentation Specialist is responsible for using professional concepts as well as company policies and procedures to manage a wide range of Planning and Procurement documentation requirements directly related to product supply.  He/she will be held accountable for independent decision making and must possess the ability to change priorities based on changing business needs while balancing multiple assignments, often with conflicting timelines. The incumbent will develop alternative solutions to problems, handle complex problems independently and demonstrate consistent application of technical and/or regulatory knowledge. This position will be responsible for executing complex assignments independently and developing solutions for defined problems by communicating effectively at all levels.  The position will be expected to lead projects of larger scope (or portions of projects) and is often called upon by peers for guidance.   The Planning Documentation Specialist must be able to analyze, communicate, negotiate, and initiate discussions regarding complex situations in order to support company success. Also may be required to coach and / or facilitate training others in his/her area of expertise and perform other duties as assigned. 

 

Primary responsibilities for role:

 

Supply Chain Documentation Specialist:

• Coordinate and manage implementation of new and/or modified packaging materials and BOMs related to Regulatory Notifications of Changes.

   - Develop implementation schedule with Sr. Supply Planner, Label Development and Procurement.

   - Issue Change Controls

   - Issue Master Data Requests

   - Issue Quality Master Data Requests

   - Issue requests to inactivate materials and BOMs no longer required as a result of changes

• Coordinate and manage Purchasing Specifications for new and/or modified packaging materials for GT and GT products packaged at GWWO.

   - Initiate Commodity Evaluation Request process for new components, if applicable.

   - Initiate new and/or modified purchase specifications using Document Change Request in DCM.

• Qualified Author for Planning, Label Development and Procurement owned controlled documents.

   - Initiate and manage revisions to current documents

   - Monitor document status to ensure required review timelines are met

   - Create new documents following approved DCM procedures as required

• Coordinate and manage implementation of new and/or modified BOMs related to major site validation projects. 

- Develop implementation scope and schedule with Project Lead, Project Owner, and/or Supply Chain representative(s).  

- Issue Master Data Requests

- Issue Quality Master Data Requests

- Issue requests to inactivate materials and BOMs no longer required as a result of changes

• May represent Supply Chain on projects, committees, and/or teams.  May also lead projects of medium complexity independently.

 

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.

 

Sr. Supply Chain Documentation Specialist:

• Coordinate and manage implementation of new and/or modified packaging materials and BOMs related to Regulatory Notifications of Changes.

   - Develop implementation schedule with Sr. Supply Planner, Label Development and Procurement.

   - Issue Master Data Requests

   - Issue Quality Master Data Requests

   - Issue requests to inactivate materials and BOMs no longer required as a result of changes

• Coordinate and manage Purchasing Specifications for new and/or modified packaging materials for GT and GT products packaged at GWWO.

   - Initiate Commodity Evaluation Request process for new components, if applicable.

   - Initiate new and/or modified purchase specifications using Document Change Request in DCM.

• Qualified Author for Planning, Label Development and Procurement owned controlled documents.

   - Initiate and manage revisions to current documents

   - Monitor document status to ensure required review timelines are met

   - Create new documents following approved DCM procedures as required

• Coordinate and manage implementation of new and/or modified BOMs related to major site validation projects.

   - Develop implementation scope and schedule with Project Lead, Project Owner, and/or Supply Chain representative(s).

   - Issue Master Data Requests

   - Issue Quality Master Data Requests

   - Issue requests to inactivate materials and BOMs no longer required as a result of changes

• May represent Supply Chain on projects, committees, and/or teams.  May also lead projects of medium complexity independently.

 

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.

 

Additional Responsibilities:

Supply Chain Documentation Specialist/Sr. Supply Chain Documentation Specialist:

May lead participate on cross-functional teams.  Must operate in a highly regulated (cGMP) environment and have a strong understanding of cGMP documentation and regulatory requirements.  Interact daily with all levels of employees to include Managers, Directors, Purchasing, Regulatory, Quality Operations, Label Development, Supply Planning and Engineering to ensure supply plan and other key business objectives are achieved. Strong negotiation skills with the ability to influence others to achieve the company’s vision.

 

Knowledge, Skills, and Abilities:

Supply Chain Documentation Specialist/Sr. Supply Chain Documentation Specialist:

Excellent oral and written communication skills, adaptable to different audiences. Agile and able to manage complex and dynamic variables.  Must have excellent organizational skills, the ability to manage multiple concurrent projects and deadlines, and the ability to develop alternate strategies and influence others.  Ability to develop customer relationships through collaboration, respect, professionalism, trust, and integrity.  Strong knowledge of cGMP documentation and change control systems including experience with DCM.  Proficient in SAP ERP system and Microsoft Office.  Strong decision making skills.  Makes key decisions impacting overall business objectives.

 

 

Education:

Supply Chain Documentation Specialist/Sr. Supply Chain Documentation Specialist:

Bachelor's Degree in Business, Science or related field required.  An equivalent combination of education and experience may be considered. 

 

 

Experience:

 

Supply Chain Documentation Specialist:

At least four (4) years applicable work experience in a cGMP role with NLT two (2) years direct experience with cGMP documentation.  Knowledge of SAP Bills of Materials required.

 

Sr. Supply Chain Documentation Specialist:

At least six  (6) years applicable work experience in a cGMP role with NLT two (2) years direct experience with cGMP documentation.  Knowledge of SAP Bills of Materials required.

 

 

Equivalency

Supply Chain Documentation Specialist:

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.  Example:  If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

 

Sr. Supply Chain Documentation Specialist:

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.  Example:  If a job level requires a Bachelor’s degree plus 6 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 8 years of experience, or a Master’s degree with 4 years of experience.

 

 

Occupational Demands:

Supply Chain Documentation Specialist/Sr. Supply Chain Documentation Specialist:

Occupational Demands Form # 10:  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. Repetitive hand movement of both hands with the ability to make fast, simple, repeated 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. Frequently drives to site locations with occasional travel within the United States and infrequent international travel. 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.

 

 

Job Level

Supply Chain Documentation Specialist/Sr. Supply Chain Documentation Specialist:

Works on assignments with a diverse scope and varied level of difficulty with limited direct supervision.  Routinely demonstrates mastery of technical skills, creativity, collaboration with others and/or independent thought.  May participate on project teams representing Supply Chain and/or lead functional area teams.

 

 

Supervision

Supply Chain Documentation Specialist/Sr. Supply Chain Documentation Specialist:

Normally receives little instruction on day to day work, general instructions on complex, new assignments. 

 

 

Decision Making

Supply Chain Documentation Specialist/Sr. Supply Chain Documentation Specialist:

Exercises judgment within defined procedures and practices to determine appropriate action.

 

 

Interaction and Influence

Supply Chain Documentation Specialist/ Sr. Supply Chain Documentation Specialist:

Interacts with cross-functional personnel at all levels throughout the site.  Provides information to management for the purposes of influencing site priorities.

EOE D/M/F/V

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