Document Control Associate, Quality Assurance
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
Reporting to the SR. Manager, Quality Assurance (QA) Document Control (DC), the DC Associate, QA will have responsibilities for the technical and administrative support of the GxP regulated functional departments and their clients. Activities will include, but are not limited to, assessment of sitewide procedures, documents and records to support compliant GMP operations at the Sanford, NC manufacturing facility. Responsibilities include ensuring adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures. This position works closely with colleagues from our Manufacturing, Engineering, Validation, Supply Chain, Facilities, QA Ops & Systems, and other GxP supporting functions to ensure compliance to Good Documentation Practices (GDP).
Responsibilities:
Collaborate with cross-functional departments to ensure timely implementation of document change requests and change control associated tasks.
Facilitate 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
Review, edit, format master documents according to approved procedures and templates, maintains document properties (metadata), monitor document status and approval notifications, distributions and archiving
Collaborate with cross-functional departments to ensure timely implementation of document change requests and change control associated tasks
Issue effective documents including logbooks, procedures, test methods, specifications, batch documentation and labels and maintain issuance logs
Execute duties associated with controlled document change requests (i.e., document formatting, approvals, effectiveness, and distribution)
Assist with and provide on-going user support for electronic document management system
Provide day-to-day operation support for departments (e.g. scheduling, reporting, records archiving)
May also support the preparation and hosting of internal audits and regulatory (e.g. FDA, EMA, DHHS, etc.) inspections
Required Qualifications:
AS degree and 4+ years of experience or B.S. degree and 2+ years of experience in a related function, 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
Excellent oral and written communication skills
Successful history working in a fast-paced team environment, meeting deadlines, and prioritization of work from multiple projects
Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others
Physical Requirements: Able to frequently lift, carry or move and position objects weighing up to 30 pounds. Able to bend, stoop and crouch to inspect materials or place labels. Consistently able to move about to coordinate work
The DC Associate, QA must be able to work flexible hours
Be able to model our Core Values: Be Bold, Care Deeply, #GetStuffDone – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted
May Have/Preferred
Experience reviewing and approving commissioning and qualification documentation.
Experience in a facility startup and licensure environment.
Experience working in a commercial-ready gene therapy facility.
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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Category Development QA
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans