Shire Documentation Specialist II in Lexington, Massachusetts

Primary Duties:

The Process Documentation Writer II is responsible for the development, creation, and revision of controlled manufacturing documentation in accordance with GMP standards. Will partner with SME’s from cross-functional teams to ensure that all controlled documents being revised contain pertinent information pertaining to process, product, and equipment specifications and are mastered within project timelines.

The Process Documentation Writer II will manage documentation review and revision process. Establish all documentation review and revision projected timelines and set priorities. Support development of business tools in an effort to increase department efficiencies.

The Process Documentation Writer II will develop and implement best practices, standards, templates or guidelines that will result in consistent, reproducible operational and business processes.

Responsibilities:

50%:

Responsible for GMP documentation process in support of manufacturing operations including:

  • Initiate and revise SOPs, Batch Records, and Form Preps.

  • With minimal supervision, manage all documentation timelines.

  • Ensure documents are reviewed periodically to meet or exceed compliance expectations.

  • Identify and lead required documentation revisions.

  • Address Next Revision Suggestion Form (NRSF) items.

  • Provide expertise and leverage best practices to technicians and support groups when reviewing draft SOPs and Batch Records/Form Preps.

  • Partner with support groups and consult with supervisors and technicians to coordinate documents for major projects or change management.

20%:

  • Responsible for partnering with support groups for the timely initiation and completion of change controls, CAPAs and subsequent action items.

  • With minimal supervision, develop timelines for documentation revisions and reviews to align with Quality System needs.

  • Own and manage CAPA and Quality System Action Items resulting from documentation revision work flows.

15%.

  • Monitor and trend effectiveness of documentation modifications

  • Challenge system and look for areas of improvement to increase efficiencies and decrease document cycle times

15%:

  • Support coordination of documents related to major projects or changes to process or systems.

  • Develop and manage documentation schedules to meet project timelines.

Education & Experience Requirements:

  • Bachelor’s degree (or equivalent combination of education and relevant experience)

  • 2 – 6 years relevant experience in a life-sciences related field.

  • Previous technical writing experience required.

Other Requirements:

  • Is identified as a Subject Matter Expert in the Documentation Revision and Review process.

  • Directs the efforts of others such as project team members and outside resources.

Notice to Employment / Recruitment Agents:

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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Reasonable Accommodations

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.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.