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Specialist, Quality Engineer

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 .

Purpose and Scope:

The Specialist, Quality Engineer will provide input and oversight to ensure compliant operations are effectively established and maintained through implementation, execution, and assessment of quality systems, procedures, and records to support compliant GMP operations. The Specialist, Quality Engineer will be tasked with performing a wide variety of activities to ensure that Astellas Quality requirements are being fulfilled through adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures. This position works closely with Manufacturing, Engineering, Facilities, Document/Data Management, Quality Assurance, Quality Control and other GxP supporting functions to ensure compliance.

Essential Job 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.

+ Perform operations ancillary documentation review/approval, including but not limited to logbooks, work request, etc.

+ Perform Quality oversight of calibration and maintenance programs within the CMMS

+ Provide Quality oversight of the facility EMS program.

+ Provide Quality oversight of Facility programs such as pest control and access control.

+ Provide Quality review and approval of Engineering drawings within the Engineering EDMS.

+ Author, review, and approve controlled documents for the Quality organization and other GMP functional areas including SOPs, protocols, and reports.

+ Quality oversight to ensure documentation generated meets internal policy, procedures and regulatory expectations.

+ Author, execute, review, or approve Quality Management System records, including but not limited to non-conformances and change controls.

+ May facilitate risk assessments with cross functional teams in support of projects, programs or Quality System Records.

+ Define, track, and report quality metrics relevant to job responsibilities.

+ Assist in the preparation and hosting of regulatory (e.g. FDA, EMA, DHHS, etc.) inspections as needed.

+ May perform other quality assurance activities and responsibilities as assigned.

Qualifications

Required:

+ A./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 or equivalent experienced quality professionals with 10+ years relevant quality experience in a biologics manufacturing facility.

+ Strong understanding of FDA, EMA, and ICH regulations and guidelines, as well as 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.

+ Critical Quality Thinking skills as well as strong decision-making skills.

+ Advanced computer skills.

+ Off-hour coverage and flexibility may be required.

Preferred:

+ Experience working in a clinical and commercial manufacturing environment (Drug Substance and Drug Product)

+ Experience working in a sterile fill/finish facility.

+ Experience working with Computerized systems, e.g. Microsoft Office, CMMS, TrackWise, EDMS, and Building Management System (BMS)

Working Environment:

+ This position is based at Astellas Sanford Technology Center in Sanford, NC and will require on-site work at a cGMP regulated manufacturing facility.

+ On occasion, this role may travel to other Astellas facilities (0-5%)

**Salary Range** **:** $93,100 – $146,300 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)

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

+ Company fleet vehicle for eligible positions

+ Referral bonus program

\#LI-TD

Category BioPharma QA

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

EOE including Disability/Protected Veterans