Takeda is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
The position will support the operation of a new, state-of-the-art plasma fractionation facility that will bring Takeda additional capacity for testing, purification and fill finish for its biologic medications.
Responsible for timely release of production lots within the QA fractionation organization.
Responsible for providing Quality Assurance support for Fractionation manufacturing process as needed. Provides Quality oversight of operation activities, review batch related document. Use of Electronic Batch Management (EBM) system. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Takeda quality practices. Interacts frequently with functional peer, and provide coaching, training and development of subordinates. The incumbent will demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, and problem solving.
Essential Duties and Responsibilities:
Perform QA Release Function:
Complete product C of As
Release production lots based on product specifications
Update metrics biweekly
Maintain task Tracker
Follow up with supporting departments on deliverables
Identify and escalate issues
Perform product holds, tagging and un-tagging of non-conforming material in a timely manner
Review documentation for accuracy and compliance to procedures, and release and reject as appropriate.
Review electronic batch records, identify nonconformance s and participate in investigation and Corrective and Prevention Action(CAPA) activities
Provide training and coaching to local employees and others as needed on relevant area(s).
Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
Promote continuous improvements through participation (i.e. team leader/facilitator or major contributor) in the Quality Improvement Program.
Participate in QA multi-site projects in the role of contributor, coordinator or lead.
Other duties, tasks or projects as assigned.
Will be working 8 hour on 1st shift
May be required to travel to local and international work locations for extended periods of time for training.
Education and/or Experience:
BS in Science / Business or equivalent. 3-5 years exp. in Quality with a medical device/Pharma company or other similarly regulated industry.
Strong interpersonal skills and great attention to detail are necessary.
Must be a team player with good problem solving, and good verbal and written communication skills.
Must have the ability to encourage teamwork and drive decisions.
Must be able to handle multiple projects concurrently.
Must have adequate computer experience (knowledge of Microsoft Word, Excel and PowerPoint required
Knowledge of TrackWise, Delta V and Electronic Batch Record Management preferred
Must have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.