What are the responsibilities and job description for the Document Control Specialist position at Astellas Pharma?
Document Control Specialist
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 .
About Astellas Gene Therapies
Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.astellasgenetherapies.com.
The Role
The primary purpose of a document control specialist is to provide technical and administrative support to the research and technical operations division. Activities will include, but are not limited to, assessment of sitewide procedures, documents, and records to support compliant operations. Responsibilities include ensuring adherence to agency regulations and guidance, industry best practices, local regulations, and internal policies and procedures. This position works closely with colleagues from our Research Quality Assurance, Records & Information Management, and Data Analytics and Technology and other GxP supporting functions to ensure compliance to Good Documentation Practices (GDP).
Responsibilities
Collaborates with cross-functional departments to ensure timely implementation of document change requests and associated change control associated tasks as required.
Facilitates the life cycle of master documents (including but not limited to SOPs, Batch Records, Test Methods, Protocols, Reports, Specifications, etc.) by functioning as a document workflow coordinator.
Reviews, edits, and formats master documents according to approved procedures and templates, maintains document properties (metadata), monitors document status and approval notifications, and prepares distributions and archiving.
Issues documents, including logbooks and labels, and maintains issuance logs.
Assists with, and provides, on-going user support for electronic document management systems.
Provides day-to-day operations support for departments (e.g. scheduling, reporting, records archiving).
Working with department heads, administrates departmental training curriculum updates in the Learning Management System (LMS) based on changing needs of departmental training plans and as training documents become effective, updated, or retired.
Ensures quality driven learning needs are deployed in the LMS; including procedural training, online courses, instructor led courses, working with Quality Business and LMS Stakeholders as required.
Management and administration of Veeva Quality Management Systems (QMS) and Quality Docs.
May also support the preparation and hosting of internal audits and regulatory (e.g. FDA, EMA, DHHS, etc.) inspections.
Organizational Context
This position reports to the Associate Director, Data Systems & Controls.
This position is an individual contributor role.
This is a hybrid position requiring working onsite up to 4 days per week and one day of remote work.
Required Qualifications
B.S. degree and 6 years of experience in a related function, preferably in a biologics research or manufacturing facility.
Minimum 5yrs document control experience out of GxP enviornment
Previous experience using Veeva QMS and Quality Docs
Excellent communication and interpersonal skills
Strong work ethic with a passion for working in a fast-paced, dynamic and diverse work environment
Ability to exercise sound judgment, tact, diplomacy, integrity and professionalism in all interactions.
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.
Proficient in MS Office Suite
Preferred Qualifications
Possess strong computer and internet skills, including online document management experience and proficiency.
Experience with Electronic Document Management Systems
Excellent oral and written communication skills
Successful history in a fast-paced team environment, meeting deadlines, and priorization of work from multiple projects.
Working Conditions
Possess strong computer and internet skills, including online document management experience and proficiency.
Experience with Electronic Document Management Systems
Excellent oral and written communication skills
Successful history in a fast-paced team environment, meeting deadlines, and priorization of work from multiple projects.
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.
Category GT - Engineering & Facilities
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
