Specialist II/ III (Manufacturing Quality Systems)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Oct 27, 2020
Ref
R-119264
Required Education
Bachelors Degree
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

• Under general supervision, analyzes production specifications and plant capacity data
• Performs calculations to determine manufacturing processes, tools and manpower requirements
• Recommends measures to improve production methods, equipment performance and quality of work
Job Purpose:

Responsible for providing quality system leadership and support to primary and secondary manufacturing areas within the Seqirus Vaccines manufacturing facility located in Holly Springs, NC.
  • Level will be determined based on years of experience.


Major Accountabilities:
  • Demonstrates mastery of multiple Quality Systems such as Deviations, CAPAs, Change Controls, Training and Inspection Readiness.
  • Demonstrates mastery of deviation process and root cause analysis in order to own critical and complex major deviations.
  • Writes Product Impact Assessments for all levels of Deviations. Leads cross functional investigation teams for all level of deviations.
  • Leads large cross-functional investigation teams for all level of investigations.
  • Creates and executes CAPA plans to reduce the likelihood of reoccurrence.
  • Owns all levels of change controls including site wide change controls.
  • Accountable for 1 or more quality system within manufacturing. Responsibilities would include tracking and trending of system performance, mitigation of system risks, training of specialists and allocation of resources.
  • Writes Biological Product Deviation Report for submission to the FDA.
  • Trains and mentors specialists on Quality Systems and business processes associated with Deviations, CAPAs and Change Controls.
  • Performs Product Technical Compliant and Adverse Event investigations.
  • Creates inspection ready plans. Acts as main point of contact for self-inspections. Presents and defends Deviations, CAPAs and Change Controls to regulatory agencies
  • Provides technical support with multiple unit operations. Identifies solutions to address technical problems.
  • Writes technical training material for manufacturing processes.
  • Provides support with multiple business process systems to support all areas of manufacturing. These system include SAP, LIMS, Data Historian, and Sentry/Trackwise


Minimum Qualifications
  • Bachelor's degree in Science or Engineering with a minimum of 3+ years' experience OR equivalent industry experience (pharmaceutical, biotechnology, and/or sterile production environments)
  • Minimum of 1 year of direct work experience with Deviations, CAPA's, Investigations, and Change Controls (3 years preferred)
  • Direct experience within a cGMP environment required
  • Experience with deviation investigations and root cause analysis
  • Experience with CAPA management and Change Controls
  • Demonstrated troubleshooting skills
  • Strong organizational, planning and time management skills
  • Strong oral, written and interpersonal communication skills