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Quality Assurance Manager

CSL Plasma
Whitestown, IN
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Position reports to:  Sr. Manager, Head of Supply Chain Quality

Responsibilities

  • Plan, implement and monitor Quality Assurance program performance to align with the Company Quality Manual.
  • Ensure the PLCs (plasma logistic centers) operate in compliance with all relevant international, federal, state and local regulations and company policies and procedures.
  • Interact with Behring facilities to facilitate change and resolve issues related to supply chain issues.
  • Ensures compliance with the document policies and procedures.  Resolve and respond to customer complaints and nonconformities in a timely manner.
  • Manage and monitor PLC quality systems to comply with relevant International, FDA, State, OSHA and company policies and procedures, including standards.
  • Oversee the collection, evaluation and distribution of the PLC(s) quality tracking and trending data and provide to operations and quality management.  Initiate applicable process improvements or training programs designed to correct and prevent nonconformities.
  • Host PLC regulatory audits, to include:  FDA, GHA, CSL Behring, customer and vendor.  Addresses findings to the satisfaction of the audit group.
  • Act as Quality Assurance GMP approver for all LOGIC changes that may affect GMPs.  Act as a Subject Matter Expert for future releases of LOGIC software.
  • Serve as change coordinator for Global and local change controls.  Examples are the annual GMP integration for Plasma and the Behring manufacturing sites, PLC process improvements which impact manufacturing sites.
  • Work with fractionators, Plasma US, Plasma EU and Global Quality to resolve issues involved Global Deviation notices.

Requirements

  • Bachelor's degree in Medical or Biological Sciences strongly preferred .
  • Minimum 5 years' experience successfully serving in a leadership role within an FDA or other regulated industry required.
  • Minimum 2 years experience related to collection, testing, preparation, storage or storage of plasma or blood components.
  • Minimum of 2 years managing people required.
  • Experience managing in a warehouse environment or similar manufacturing environment.
Company Description
Supported by parent company CSL Behring, the global leader in plasma protein biotherapeutics, CSL Plasma has more than 300 plasma collection centers globally. CSL Plasma also has a state-of-the-art testing laboratory that features some of the most advanced technology, instrumentation and automation in the field; two logistics centers, one in Dallas and one in Indianapolis. Our corporate headquarters is in Boca Raton, Florida.

Our U.S. plasma collection centers are committed to the highest standards of quality and safety. When you donate, you give a valuable gift to those who require plasma-derived therapies to live healthier lives.

The CSL Group has a combined heritage of outstanding contribution to medicine and human health with more than 100 years’ experience in the development and manufacture of vaccines and plasma protein biotherapies.

With major facilities in Australia, Germany, Switzerland and the US, CSL has over 30,000 employees working in 100 countries.

CSL Plasma

Address

3750 Perry Blvd.

Whitestown, IN
USA

Industry

Technology

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