QA Document Control Specialist

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QA 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 .

The Role

The QA Specialist, Document Control will provide day-to-day support to ensure a compliant Document Control program is effectively maintained. This role will have a responsibility for reviewing and identifying opportunities to proactively assure compliance to all applicable internal, domestic, and international quality regulations. This role is the first point of contact for ensuring activities required to implement effective procedures, documents and records to support a cGxP-compliant Document Control program for AGT biological products are carried out to completion. Responsibilities include ensuring adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures.

Responsibilities

• Provide daily support of GMP Document Control tasks including but not limited to review of documents for adherence to local and global requirements, controlled print issuance and reconciliation, archive records indexing/management, etc.
• Execute daily program level responsibilities, including development and implementation of processes and continuous improvements to ensure productivity and alignment with departmental/site/global goals.
• Establish and foster a cGMP quality culture that prepares the site for regulatory pre-approval inspections and eventual licensure for commercial manufacturing.
• Provide support to Manufacturing, Facilities, Supply Chain, and other supporting function authors and reviewers/approvers to ensure compliant documents/records.
• Assist in the implementation of global systems for Document Control program, including implementation and release of future changes.
• Build relationships with key counterparts and stakeholders across campuses to establish aligned QA Document Control program and related processes that meet both regulatory guidance and company policies.
• Assist Document Control senior level colleagues in partnering with area leadership to develop and provide instruction for site-level training curricula program to authors, reviewers/approvers of GxP documentation/records.
• Participate and represent the company in regulatory (e.g., FDA, EMA, DHHS, etc.) inspections and audit activities conducted by third-party and corporate partners as quality process owner for documentation programs.
• Performs other duties as assigned.
  
  

Required Qualifications

• Bachelor’s degree in a related scientific or technical discipline with 2 years of experience in biotechnology or pharmaceutical industry specifically in the area of QA Document Control program operations and/or related quality function in a regulated industry.
• Working knowledge of US and International GMPs, FDA/ICH Guidance, and best practices in a biotech manufacturing and testing environment.
• Proven ability and enthusiasm to lead, motivate, inspire, develop, and encourage colleagues.
• Well-organized and detailed oriented professional, with strong verbal and written communication skills.
• Advanced computer skills with working knowledge of MS office such as Word, Excel, and Adobe Acrobat.
• Must be self-motivated with ability to handle, organize and prioritize multiple tasks and be able to perform under pressure to meet production deadlines.
• Proven experience with electronic document management system(s) and electronic signatures.
  
  

Preferred Qualifications

• Experience in a GMP facility startup, high growth, and fast-paced environment.
• Experience working with Quality systems in a commercial-ready gene therapy facility.
  
  

Working Environment

• This position is based in Sanford, NC and will require on-site work in a cGMP regulated manufacturing facility.
• On occasion, this role may travel to other Astellas facilities (0-5%).
  
  

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 BioPharma QA

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans

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