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 Quality Assurance Specialist III in our Cambridge, MA office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Quality Assurance Specialist III working on the Quality Assurance team, you will be empowered to represent Takeda on cross-functional project teams and ensure our quality culture is maintained. A typical day will include:
- This individual will be responsible for lot review/release activities for commercial drug substance, drug product and finished goods manufactured by international CMOs.
- This individual will support project activities, validation, investigations, product complaints, and other quality systems as they relate to commercial manufacturing.
- This person will be critical in providing quality oversight and coordination of QA activities at CMOs.
- This person will be responsible for coordinating/performing assigned investigations including drafting excursion reports for review.
- This person will be responsible to participate in assigned project teams as QA representative.
- This person will be responsible to draft and implement change controls. Responsible for managing own workload from multiple project managers to meet deadlines.
- Performs documentation review thoroughly, with a high attention to detail, using working knowledge of quality concepts and internal procedures and controls.
- Perform reviews of deviations and investigations, equipment, process and method validations as well as of executed batch records.
- Maintains sufficient expertise in one or more QA disciplines to independently perform analysis and draw appropriate conclusions. Communicates with manager and other stakeholders (internal and external) to ensure communication of outcomes.
- Responsible for leading departmental projects for process improvement and other projects as assigned by their manager.
- Responsible for actively participating in group training and coaching efforts. Positively influences peers in achieving operational and project initiatives and objectives. Is a recognized technical and procedural resource for peers.
- Proactively monitors discipline of expertise for issues. Initiates solutions and preventative actions.
- Maintain Master Batch Records and provide support for regulatory filings and change controls.
- Provide support for regulatory inspections and GMP audits.
- Responsible for engaging in regular contact with external organizations. Acts as liaison with new vendors and independently resolves issues with vendors.
- Responsible for independent technical and non-technical troubleshooting. Serves as a representative to cross functional troubleshooting teams.
- Identifies and resolves basic technical issues using problem-solving skills, in consultation with Manager.
- Independently revises department-specific controlled documents.
- Responsible for independent decision making and routine issue resolution. Keeps Supervisor informed of activities and issues.
- Participates in required training and keeps training files current.
- Independently performs assigned tasks in the design and implementation of departmental process changes and other projects as assigned.
- Able to identify complex problems and consistently propose solutions. Reviews goals and plan regularly and realign priorities consistent with organizational shifts. Continually seeks creative process improvements.
- Actively integrates big picture understanding into all interactions. Drives team cooperation and credibility focusing on positive results. Encourages communication, cooperation and win/win solutions.
- Responsible for coordinating activities to administer assigned tasks. May coordinate activities cross functionally.
- Influences others to focus on goal attainment by actively generating solutions to wide range of challenges.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- BS and 4+ years experience with 2 in QA or related compliance experience or MS and 2+ years QA experience. Experience may be substituted for degree.
- Solid understanding of applicable regulations and guidance. Demonstrates expertise of department processes, tools and methods.
- 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 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.
- Willingness to travel to various meetings or client sites, including overnight trips.
- Requires approximately 0-10% travel.
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.
No Phone Calls or Recruiters Please.