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The Quality Documentation Specialist is responsible for the development, creation and revision of controlled manufacturing documentation in accordance with current GMP Standards. Will lead while partnering with Subject Matter Experts from cross-functional teams to ensure that all controlled documents being created or revised contain required information pertaining to process, product and equipment specifications and are completed within defined timelines.
Responsible for GMP documentation process in support of manufacturing operations, including:
Create and revise SOPs, Batch Records and Form Preps; Identify and lead required documentation revisions within the electronic documentation system.
Ensure consistency and alignment between documents in compliance with SOP requirements.
Address comments as provided by document reviewers.
Provide expertise and leverage best practices to manufacturing and support groups when reviewing draft SOPs and Batch Records/Form Preps.
Partner with SMEs and support groups to coordinate documents for major projects, technical transfers or changes to processes or systems.
Coordinate with the training function to ensure appropriate training materials are created with new or revised GMP documentation.
Partner with support groups for the timely initiation and completion of change controls, CAPAs and subsequent action items.
Complete action items within Quality Management System prior to the assigned due date.
CORE ELEMENTS RELATED TO THIS ROLE:
Ensure that documents contain accurate details and instructions corresponding with the activity.
Ensure that the information contained in documents correspond with the information of related documentation and that they adhere to all GMP requirements.
Support continuous improvement efforts to ensure documentation is efficient and compliant.
DIMENSIONS AND ASPECTS:
Technical/Functional (Line) Expertise
Serve as Subject Matter Expert of the document creation and revision process utilizing the electronic documentation system.
Must be a team player prepared to lead, work effectively and efficiently in a team-based environment.
Excellent communication skills required for effective partnership with manufacturing and support functions.
Decision-making and Autonomy
Support projects of routine problems of limited complexity and scope and follow established policies and procedures.
Advises, consults and collaborates with cross-functional teams including but not limited to:
Facilities and Engineering, Manufacturing Sciences, Quality, Validation, PMO, Process Development and Health, Safety & Environment.
Must be proficient with Microsoft Office applications, including Word, Excel and PowerPoint.
Experience with more advanced document management applications a plus (including but not limited to EDMS and TrackWise).
Works independently with minimal supervision to execute all facets of projects/initiatives.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Bachelor’s degree (or equivalent combination of education and relevant experience).
2+ years relevant experience in a life sciences-related field.
Previous technical writing experience preferred.
Excellent communication, technical, organizational, interpersonal and leadership skills are
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Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
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