Quality Assurance Specialist - MLCM
, Georgia
October 22, 2017
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 Ophthalmic.

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.

Issues, resolves and mitigates Supplier Corrective Action Reports (SCARs) issued to supplier for a nonconforming material.
Manages relationship with suppliers and issue resolution, and drives supplier improvements in the assigned commodity to ensure business continuity. Facility Representative for MLCM in making quality related decisions on behalf of the function.
Issues and manages material specifications for commodities, suppliers assigned by the MLCM team.
Able to identify and assess quality risk in activities and processes according to guidelines and Shire standard operating procedures. Participates in internal/external audits.

  • Document owner and approver for material quality and technical documents
  • Manages relationship with suppliers to obtain issue resolutions
  • Resolves complex problems, is accountable for problem identification, root cause analysis and managing resolutions, including Supplier Corrective Action Reports (SCARs)
  • MLCM representative to Covington project teams as requested
  • Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements
  • Owns and processes change controls for specifications and documents to support the MLCM organization
  • Provides leadership for tactical and strategic for business needs
    Education Requirement

    Essential: Bachelor degree Sciences or Engineering or related field with a minimum 5 years of experience in the biotechnology, biologics or pharmaceutical industry.

    Desired: Previous experience in pharmaceutical manufacturing and quality operations preferred.

    Key Skills and Competencies

  • Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:
    Leadership Behaviors
    • Be Positive
    • Be Accountable
    • Be Results Oriented
    • Be An Excellent Manager of Self and Others
  • Expertise in cGxP regulations and compliance requirements
  • Respect for individuals and the diverse contribution of all
  • Thorough knowledge of applicable healthcare procedures, specifications, regulations and standards.
  • Highly experienced professional, providing process and program design advice
  • Simplify the complex without losing the overview
  • Ability and willingness to adapt in course of changes
  • Fluent in English (verbal, written and oral)
  • Good knowledge of MS office
  • Proficient in multiple quality systems including supplier quality, statistical techniques, regulatory requirements, documentation control, Material Management/Material Qualification Processes etc.
  • Proficient in complex problem solving through the use of quality tools.
  • Thorough technical capabilities
  • Resolves complex problems, is accountable for problem identification, root cause analysis and managing resolutions, including Supplier Corrective Action Reports (SCARs)

  • US and EU MLCM Commodity Managers
  • GSP (Procurement)/Supply Chain Managers
  • Facility Leadership
  • Receiving/Inspection Personnel
    Other Requirements

  • Up to 10% travel (domestic or international)
  • Must be able to lift, push, pull and carry up to 10 lbs.
  • In general, the position requires a combination of sedentary work and walking around observing conditions in the facility or at a supplier.
  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
  • No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
  • Must be able to work multiple shifts, including weekends, if needed
  • Must be able to work overtime as required
  • May be required to work in a confined area.
  • May need to enter into cool/hot storage/wet working conditions for investigations

A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.

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