Team Lead Quality Assurance - First Shift
Brooklyn Park, Minnesota
Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.
As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines.
Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business units are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Join us and discover a career that is life-changing for you – and life-changing patients all over the world.
Takeda’s Brooklyn Park manufacturing facility provides long-term strategic benefits by enhancing Takeda’s capacity to manufacture additional commercial products and investigational drugs under clinical development. This plant allows Takeda to establish and develop direct commercial bio-manufacturing expertise, and is poised to be a world-class biologics drug substance production facility. When fully constructed, it will be a 215,000 square-foot facility manufacturing multiple antibody products, including Entyvio.
We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!
What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.
Life at Takeda
Heart of Innovation
The sharing of expertise by employees who have decades of experience with younger colleagues is an essential part of our work culture, playing an important role in both fostering strong community relations, and also in ensuring we maintain the quality of our products.
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Recognized for our culture and way of working, we’re one of only select companies to receive Top Global Employer® status for 2020.
At Takeda, your determination and energy, combined with our cutting-edge technology and global R&D, offers families and communities hope for Better Health and a Brighter Future.
Learn more about Manufacturing, Supply Chain, and Quality careers within our global biopharmaceutical company.
Here, you will feel welcomed, respected, and valued as a vital contributor our global team.
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.
Team Lead Quality Assurance - First ShiftApply Now
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. A typical day will include:
- Supervise Quality Assurance Specialists involved in activities associated with commercial cGMP biologics drug substance manufactured at the Brooklyn Park site of Takeda.
- Responsible for supervising the batch record review and product disposition function in support of timely commercial drug substance batch disposition.
- 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.
- Focused primarily on providing support, guidance, and training on complex and non-routine quality-related issues.
- This is a first shift position, with periodic on-call work required for off-shift coverage to support a 24-7 manufacturing department.
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.
- 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 deviations, investigations, and CAPAs associated with cGMP compliance. Supports 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.
- Develop and provide training on department-specific procedures/systems and quality-related topics from industry. Trains and mentors peers. Ensures staff is adequately trained prior to executing work.
- Identifies and proposes Quality Process and system improvements.
- Participates in internal or supplier audits as needed.
- Complete mandatory training within required timeframe.
- Performs additional duties, as assigned.
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
No Phone Calls or Recruiters Please.
Brooklyn Park, MN
Job ID R0015510