What are the responsibilities and job description for the Specialist, Quality Assurance, Document Control position at Astellas Pharma?

Job Description

Specialist, Quality Assurance, Document Control

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.

AIRM has a world-class R D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platformsboth embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.

Astellas is announcing a Specialist, Quality Assurance, Document Control opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose :

The Specialist, Quality Assurance, Document Control, will assist in maintaining and administering all aspects of the GMP document control system compliant with international cGMP expectations and Astellas policies and procedures. Activities will include, but are not limited to, management of the Electronic Document Management System (EDMS) and its contents, word processing and formatting of documents, maintaining GMP records in the QA archive, and providing end user customer support. Participates in independent and team projects as defined by the department supervisor / manager.

Essential Job Responsibilities :

Essential Duties and Responsibilities include, but are not limited to, the following :

Assists in maintaining a document management system compliant with regulatory, quality, and AIRM requirements.
Performs QA document control functions, including document issuance, reconciliation, distribution, release, and archiving of documents.
Ensures accuracy by reviewing documents for completeness, proper authorization and impact to other quality systems.
Collaborates with cross-functional departments to ensure timely implementation of document change requests.
Investigates deviations against the document management system and develops effective corrective action plans.
May assist in providing training to new staff on document management processes and procedures.
Supports audits (internal, external) in order to verify that regulatory and quality requirements have been met.
Coordinates the revision, review, and approval and obsoletion of SOPs and other GMP documents. Responsible for ensuring area managers perform biennial review of all cGMP documents and SOPs.
Organizes and ensures accurate and reliable filing systems for all paper based GMP documents.
Maintain SOP binders and controlled copies.
Performs other duties as assigned or special projects as needed.

Requirements

Qualifications Required :

BS degree, typically 4-5 years of experience or MS degree, typically 2-3 years of experience in a related function with transferrable skills, preferably in a biologics manufacturing facility.

Possess strong computer and Internet skills, including online document management experience and proficiency in Microsoft Office (Outlook, Excel, Word, PowerPoint).

Experience with Electronic Document Management Systems.

General understanding of FDA regulations including Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP) regulations, FDA Guidance, and ICH Guidance.

Proficiency with Microsoft Word formatting tools and techniques, to include manipulation of headers / footers, page control, document sections, orientation, styles, and editing markup / tracked changes.

Excellent communication and interpersonal skills.

Ability to work independently without significant oversight or instruction to achieve results with a high degree of accuracy and attention to detail.

Proven track record of excellent judgment, problem resolution, teamwork, some budgeting and / or excel skills, decision-making skills, and the ability to work under pressure required.

Preferred :

Experience using document management software in a regulated industry.

Proficiency in MS Excel, PowerPoint, and / or Visio to include creation / formatting of charts and data tables.

Experience in an environment subject to regulatory audits.

Working Conditions :

This position is based in Westborough, MA and will require on-site work.

Benefits :

Medical, Dental and Vision Insurance

Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

401(k) match and annual company contribution

Company paid life insurance

Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

Long Term Incentive Plan for eligible positions

Referral bonus program

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

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