Senior 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 Manager, Quality Assurance (QA) the Associate II/Senior Associate, Quality Assurance will be primarily responsible for the implementation, execution, and assessment of quality systems, procedures, and records to support compliant GMP 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 Manufacturing, Engineering, Validation, Supply Chain, Facilities, Document/Data Management, and other GxP supporting functions to ensure compliance. This is accomplished by direct collaboration and oversight of Validation, Facilities/Engineering, Manufacturing Operations, 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:
Perform review and approval of master production batch records.
Author, review, and approve Quality System records including Deviation, CAPA, and Change records including associated causal and impact assessments.
Author, review, and approve controlled documents for the Quality organization and other GMP functional areas including SOP's, material specifications, validation protocols, and reports.
Develop and execute QA Area Walkthrough process.
Review and approval of Work Orders.
Review of functional area logbooks (equipment, cleaning, etc.)
Inspect and release GMP raw materials and components against approved specifications.
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.
Assist in the preparation and hosting of regulatory (e.g. FDA, EMA, DHHS, etc.) inspections, as necessary.
Proactively identify gaps or system enhancements and shepherd to completion, as required.
About you
Must Have/Required:
Senior Associate, Quality Assurance : Bachelor's degree in a related scientific or technical discipline with 6+ years of hands-on experience in a QA function in a biologics manufacturing facility or Master's degree with 4+ years of hands-on experience in a QA function in a biologics manufacturing facility or equivalent experience.
Associate II, Quality Assurance : Bachelor's degree in a related scientific or technical discipline with 4+ years of hands-on experience in a QA function in a biologics manufacturing facility or Master's degree with 2+ years of hands-on experience in a QA function in a biologics manufacturing facility or equivalent experience.
Knowledge of U.S. and international regulatory standards and guidelines
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 with rare diseases, neuromuscular diseases and/or gene therapy products
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
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Category Development QA
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans