Specialist Quality Assurance

Profile

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: ****About Astellas
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx ® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at
****Our Values:
Be
BOLD (Find a Way)
Care Deeply
for our patients, each other and our work
#GSD
(Get Stuff Done)
What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.
The Role
Reporting to the Manager, Quality Assurance (QA) the Specialist, Quality Assurance for Quality Control (QA for QC) will be primarily responsible for the implementation, execution, and assessment of quality systems, procedures, and records to support compliant laboratory operations. 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 Quality Control, Validation, Document/Data Management, and other GxP supporting functions to ensure compliance.
This is accomplished by direct collaboration and oversight of Quality Control activities and the review/audit of data and reports as specified by Standard Operating Procedures.
This position will be based in our Sanford, NC facility.
Primary Responsibilities
Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure compliance to SOPs and relevant Good Regulated Practice (GxP) requirements.
Provide QA oversight for the qualification of laboratory equipment and systems.
Provide QA oversight for the qualification, validation, and transfer of analytical methods.
Provide QA review and authorization of laboratory testing data.
Review and approve laboratory investigations.
Act as QA representative and approver for deviation investigations including Out of Specification (OOS) and Out of Trend (OOT) testing results.
Author, review, and approve controlled documents for the Quality organization and other GMP functional areas including SOP's, specifications, protocols, and reports.
Author, review, and approve Quality System records including Deviation, CAPA, and Change records including associated causal and impact assessments.
Review and approve CMMS records related to QC equipment.
Define, track, and report quality metrics.
Assist in the preparation and hosting of regulatory (e.g. FDA, EMA, DHHS, etc.) inspections as needed
Requirements
About you
Must Have/Required
QA Validation Engineer
- B.S. degree in
Biological/Physical/Chemical sciences, engineering, or equivalent focus of study and 5-8 years of experience or M.S. degree and 3-5 years of experience in a QA function in a biologics manufacturing facility
Strong knowledge of risk-based approach to commissioning, qualification and validation activities in a biotech manufacturing environment.
Strong understanding of FDA, EMA, local regulations and guidelines, Good Engineering Practices, ICH guidelines, and industry best practices.
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
Excellent problem-solving skills and experience with root cause investigations and CAPA determination
Strong computer skills including MS Office (Word, Excel)
Off hours coverage and flexibility may be required
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
Models 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 with rare diseases, neuromuscular diseases and/or gene therapy products
Experience in a facility startup and licensure environment
Experience in a commercial-ready gene therapy facility
Experience in a small company and high growth, fast-paced environment
Benefits:
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
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
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Type
Full-time
Location
NC, Sanford
Category
Quality Assurance

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