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Quality Assurance Specialist II IG/Albumin Purification Weekend Day Shift

Shire 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.

Summary:

The position will support the operation of a new, state-of-the-art plasma fractionation facility that will bring Shire 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 Shire 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 nonconformances 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.

Qualifications:

Education and/or Experience

Bachelors 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 independentlyand 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



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