Massachusetts Green Jobs

QA Compliance 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 .

Astellas Institute for Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.

AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.

Astellas is announcing a QA Compliance Specialist opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

This member of the Quality Assurance team will perform critical QA compliance tasks in support of GMP manufacturing programs as AIRM moves through clinical trials and commercialization. The successful candidate will foster compliance across a broad range of Quality Assurance areas and will work closely with talented counterparts in the Manufacturing, Quality Control, and Materials Management teams to help ensure high quality standards and value delivery for our patients.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Performs QA review of executed Manufacturing batch records, QC test records, raw material inspection records, and calibration records. Identifies and reports documentation errors and deviations from SOP or specifications in a timely manner. Tracks basic metrics on reviewed documents to support monthly reporting.

• Assists with the Deviation and Corrective / Preventive Action (CAPA) programs, aids investigations, and may assume investigation leader status for select deviation investigations. Helps ensure that deviation records are clearly written, technically sound, and provide thorough root cause analysis and risk assessment. May assist with monthly metrics and continuous improvement opportunities for these programs.

• May assist with the Internal Audit program for the organization, serving as an assistant auditor to help ensure all aspects of the GMP organization remain compliant with Astellas procedures and domestic / international GMP regulations.

• Actively participates in continuous improvement opportunities to identify efficiencies and compliance improvements to benefit department operations or the organization at large.

• Authors (or assists in authoring) new or revised standard operating procedures (SOPs) for the QA department to satisfy new compliance requirements or improve work practices.

• May assist senior QA staff in oversight of contract manufacturing organizations (CMO), monitoring information requests, reviewing CMO work, and following up on other compliance items.

• Performs other duties as assigned or special projects as needed.

Qualifications:

Required:

• BS degree with 3+ years or MS with 0-2 years of laboratory experience

• Working fluency, the Microsoft Office productivity suite (including Excel and PowerPoint).

• Experience with Electronic Document Management Systems

• Excellent oral and written communication skills

• Demonstrated knowledge of cGMPs

• Highly organized with a strong attention to detail

• Proven ability to manage both day-to-day operations, as well as project work in a fast-paced environment.

Preferred:

• Demonstrated knowledge of cGMPs for biotechnology. Working understanding of ICH Q7, Q8, Q9, Q10 and other international regulatory requirements.

• Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions, and exercise sound Quality-by-Design principles. Experience presenting these outcomes to management.

• Specialized knowledge of any industry-related niche topics: bar coding, cell culture, auditing techniques, QC methods, HEPA filtration science, etc.

• Previous experience interacting with regulatory agencies, representing technical deliverables as a subject matter expert, audit hosting / support, etc.

• ASQ certifications (e.g., certified quality engineer, quality auditor, quality professional, etc.)

Work Environment:

• This position is based in Westborough, MA and will require on-site work.

• This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs

• This is an on-site role working in a cGMP regulated manufacturing 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

Compensation: $74,300 – 99,000 (NOTE: Final salary could be more or less, commensurate with experience)

#LI-LK

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