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Senior Quality Assurance Operations Specialist


Takeda Pharmaceutical


Cambridge, United States

United States

IT Security




Not specified

Permanent | Full Time

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role:You will provide senior level support for issues of moderate complexity at a minimum. Routine management & coordination of GMP compliance systems and policies for cGMP compliant facilities. Approval of Quality Systems which include deviations and CAPA and supporting disposition. You will provide senior level support for issues of moderate complexity at a minimum. You will report to the Head of Quality Assurance. Position based in Lexington, MA.How you will contribute:You will monitor policies procedures and established standards and agency guidelines to ensure lasting customer satisfaction. Demonstrate high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained, with multiple departments to ensure appropriate TCA and CAPAs have been identified.Examine programs to create efficiencies in practices and use of staff. Review production records for compliance. Assure cGMP's and company procedures are followed and, if needed, procedures are revised. Meet functional area goals as they relate to departmental and company-wide goals. Follow GMP regulations, cGMP's, company policies, and leadership capabilities.Minimum Requirements/Qualifications:B.S. degree in science or engineering with 5+ years relevant experience developing, or administrating GMP quality programs in biotech or pharmaceutical environments.Knowledge of FDA and EMEA regulations and working knowledge of root cause analysis.Desired: Direct Biologic Pharmaceuticals experience within Technical OperationsWhat Takeda can offer you:Comprehensive Healthcare: Medical, Dental, and VisionFinancial Planning & Stability: 401(k) with company match and Annual Retirement Contribution PlanHealth & Wellness programs including onsite flu shots and health screeningsPaid time off for vacation, sick leave, and volunteeringCommunity Outreach Programs and company match of charispan contributionsFamily Planning SupportProfessional development opportunitiesTuition reimbursementImportant ConsiderationsAt Takeda, our patients rely on us to create quality products and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. You may:Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.Need to remove all make-up, jewelry, contact lenses, nail polish or artificial fingernails while in the manufacturing environment.Work in a cold, wet environment.Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.More About UsAt Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.You will be classified as "hybrid" observing Takeda's Hybrid and Remote Work policy.Follow the CO Equal Pay Act, Colorado You Are Not Permitted to Apply.#GMSGQ#Quality Assurance#biologicsEEO StatementTakeda is proud in its commitment to creating a perse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsUSA - MA - Alewife - BIO OPSWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

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