Shire Quality Documentation Specialist in Lexington, Massachusetts

Primary Role

Lead the coordination and management of GMP documentation systems and policies for Lexington Site (Lexington & Alewife) operations usage. Assures cGMP’s and company procedures are followed at all times from; planning, through issuance, reconciliation and the subsequent archival of all controlled documents. Accountable for meeting functional area goals and objectives as they relate to departmental and company plans. Responsible for adhering to GMP regulations, cGMP’s, company policies, and operational excellence practices and principles.

Essential Functions

Responsibilities

Direct responsibilities include:

  • 40% The oversight and management of controlled cross-site production documents. All documents to be managed with GMP compliance throughout their lifecycle (including; planning, issuance, storage and archival).

  • 15% Direct management, organization, and maintenance of cross-site controlled documents archive rooms. Ensures that controls are in place to protect against removal or modification of records.

  • 15% Provides support, guidance, and/or oversight as needed to contractors, employees or any personnel assigned to assist with any aspect of controlled documents planning, issuance, reconciliation, and/ or archival. Work with responsible area management to give relevant feedback (positive or negative) as appropriate.

  • 10% Provides customer service and assistance for users needing information or access to; document issuance, reconciliation and/or archival materials or rooms.

  • 10% Maintain inventory of all records to support retrieval for business use, inspection, and/or destruction including off site vendor storage.

  • 10% Maintain batch record SharePoint site, associated quality systems and related trainings as required

Education & Experience Requirements

  • A Minimum HS Diploma, documented GMP training, and a minimum of 3+ years of relevant industry experience.

  • Excellent interpersonal skills and the ability to communicate well orally and in writing.

Other Requirements

Must be flexible to work on call on ad-hoc basis.

Key Leadership Capabilities:

  • Proficiency/Excellence in all job scope capabilities

  • Accountability & Ownership

  • Delivering Excellence

  • Self-Knowledge

  • Judgment and Decision Making

  • Energy and Drive

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.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

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.