Specialist/ Sr. Specialist, QC (Chemistry Investigations and Deviation Management)

CSL Behring
Holly Springs, North Carolina
Apr 08, 2021
Required Education
Position Type
Full time
About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Job Purpose:

Ensures compliance of the Quality Control Department to Seqirus Quality systems by supporting Deviation Management, Change Management, Work Order Management, Learning Management and Document Revisions for the Quality Control department.

Major Accountabilities:
  • Leads deviation (DR) investigations to adequately identify root cause and implement appropriate corrective and preventative actions (CAPAs) to prevent reoccurrence. Employs standardized root cause analysis, investigation tools and methodologies.
  • Owner of QC change management records, including Change Controls (CC), Corrective Actions/Preventative Actions (CAPAs) and Document revision workflows to support the Quality Control department.
  • Utilize Investigation and Deviation systems for owning QC investigations, tracking statuses, leading investigations teams and serve as QC liaison with other department investigation writers to ensure complete and timely resolution.
  • Participates in continuous improvement programs to eliminate non-value add activities/maximize efficiency.
  • Provides support with assigned business process systems to support QC. These systems include SAP, LIMS, EDMS, LMS and Trackwise.
  • Responsible for the Work Order Tracking system for tracking and coordinating the initiation, execution and completion of work orders.
  • Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written.
  • Responsible for reviewing trends of QC deviations and investigations to identify areas requiring additional action.
  • Maintains departmental metrics and key performance indicators (KPIs) for Senior leadership review.

Minimum Qualifications:
  • Bachelor's degree required.
  • Minimum of 3 years' experience required.
  • Knowledge of HPLC, UPLC, Raw Materials testing and USP/EP Compendia preferred
  • Basic knowledge of cGMP and FDA requirements preferred
  • Knowledge of Laboratory Systems and Investigation/Deviation writing required
  • Knowledge of Laboratory Systems and Change Control/CAPA writing required
  • Excellent organizational, planning and time management skills.
  • Strong oral, written and interpersonal communication skills. Demonstrated technical writing skills.
  • The ability to work effectively in both a team environment and an individual contributor role.