Lead Quality Assurance Specialist - Second Shift


Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Lead Quality Assurance Specialist in our Brooklyn Park, Minnesota office.


Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Lead QA Specialist working on the Quality Assurance team, you will be empowered to supervise QA Specialists as well as batch record review, and a typical day will include:


OBJECTIVE:
•This individual will supervise Quality Assurance Specialists involved in activities associated with commercial cGMP biologics drug substance manufacture at the Brooklyn Park site of Takeda.
•This person is responsible for supervising the batch record review and product disposition function in support of timely commercial drug substance batch disposition.
•This person provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies related to quality assurance operations, and may support and/or represent the Quality Assurance functional area as a subject matter expert (SME) during regulatory and third party inspections.
•This is a second shift position


ACCOUNTABILITIES:

This position is focused primarily on providing support, guidance, and training on complex and non-routine quality-related issues and for supervision of the QA Specialists.

This individual:
•Performs batch and supporting documentation review thoroughly, with a high attention to detail, using extensive working knowledge of quality concepts and internal procedures and controls.
•Interprets and executes operating policies, procedures and directives for the department.
•Provides leadership to the group. Assures quality and compliance of department work product. Maintains system for reporting department performance metrics.
•Coordinates with manufacturing and facility support staff to proactively engage in issue resolution.
•Analyzes and interprets projects, studies, or investigations to determine next steps. Makes decisions independently and notifies management of action taken.
•Identifies, investigates, and resolves complex technical issues using problem-solving skills. Notifies management of actions taken.
•Leads investigation teams and ensures proper close out and follow up.
•Reviews/approves deviations, investigations, and CAPAs associated with cGMP compliance. Initiates, monitors, and reviews/approves change controls related to Quality topics.
•Represents QA on cross-functional project teams such as tech transfer, process validation, and process improvements.
•Writes new documents and revises existing documents, independently.
•Performs QA review/approval of controlled documents.
•Receives minimal supervision on work assignments. Receives overall project direction from management, but completes most work independently.
•Participates in required training and keeps training files current.
•Develops and provides training on department-specific procedures/systems and quality-related topics from industry. Trains and mentors staff and peers. Ensures staff is adequately trained prior to executing work.
•Identifies, proposes, and implements Quality Process and system improvements.
•Participates in internal or supplier audits as needed.
•Performs additional duties, as assigned, including support of Compliance and Supplier Quality functions.


EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

BA/BS (or Master's) in any Life Science discipline preferred, and/or 8 years experience in Regulated (food, medical device, or pharma/biotech) industry.
•Must have direct experience with Quality Assurance within the Life Science industry.
•Understands and applies comprehensive knowledge of quality and GMP principles. Maintains current understanding of global GMP regulations.
•Ability to handle multiple tasks concurrently and in a timely fashion.
•Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
•Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management.
•Must be able to read, write and converse in English.
•Must display eagerness to learn and continuously improve.
•Positive work attitude that supports teamwork and continuous improvement.
•Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
•Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint.


Must have Supervisory Experience
•Delegates responsibility and projects to Quality Assurance Specialists based on their level of judgment and experience.
•Assists the Quality Manager with development of vision and goals for the Quality Assurance Specialists that are aligned with Takeda quality and global Takeda goals.
•Communicate and advocate Takeda and department goals and objectives.
•Meets with individual employees on a regular basis to discuss, prioritize, and assign work and projects.
•Independently manages personnel development, annual performance reviews and performance issues with minimal guidance.
•Structure, lead and train staff. Proactively looks for ways to challenge staff and create career opportunities to enhance job satisfaction and improve the department as a whole.
•Develops and maintains strong internal relationships both within the Quality organization and cross-functionally.


WHAT TAKEDA CAN OFFER YOU:

•401(k) with company match and Annual Retirement Contribution Plan
•Tuition reimbursement
•Company match of charitable contributions
•Health & Wellness programs including onsite flu shots and health screenings
•Generous time off for vacation and the option to purchase additional vacation days
•Community Outreach Programs


Empowering Our People to Shine


Learn more at takedajobs.com.


Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

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