Posted to MedZilla on 11/13/2019

Takeda Pharmaceuticals

US-GA, Quality Assurance Specialist II IG/Albumin Purification Weekend Day Shift SR0042699-MZ


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.

QA Associate II is responsible for, but not limited to:

Providing Quality oversight and manufacturing support as required by Operations
Performing timely review of batch record documents on the shop floor
Identifying and assessing regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Takeda quality practices
This is a weekend shift position. Training will occur on an alternate shift.
Essential Duties and Responsibilities:
Provides manufacturing floor coverage and attends daily cross-functional departmental meetings
Identifies nonconformance s and participates in investigation and Corrective and Preventative Action (CAPA) activities
Use of Quality Systems to assess product impact or review data
Authors, review and/or approves written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet requirements

Working Environment:
Will spend a portion of time in clean room environment to provide oversight to manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines
May be required to work , evenings, off-hours, and extended periods of time
May be required to travel to local and international work locations for extended periods of time for training
Training will occur on an alternate shift.

Education and/or Experience
Bachelor s degree in Engineering, Science or related field or equivalent. 2-3 years of experience required in the pharmaceutical or other similarly regulated industry preferred.

Must have the ability to engage in team activities with strong communication and negotiation skills
Must be able to work independently and have initiative to complete tasks
Must have strong analytical and problem solving skills
Must have knowledge of and understand application of Good Manufacturing Practices
Experience with Trackwise, EBM, and Delta V/PLC is preferred

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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Reasonable Accommodations

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.

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