Specialist I/II/III, QA (Bulk Manufacturing, Laboratories, and Logistics)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Oct 28, 2020
Ref
R-124067
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

Job Purpose:

The Front Line Quality Assurance (FLQA) Specialist will provide on the floor support to bulk manufacturing, laboratories, and logistics at the Holly Springs site. Core responsibilities of this role include quality walkthroughs on the floor, GMP record reviews and approvals, and real time triage of quality related issues.
  • *Ideal candidate will have experience providing QA oversight and support of a pharmaceutical QC laboratory.
  • *Hours: Monday-Friday 7am-4pm.
  • *Candidate must be flexible in their shift schedule to support the business and the seasonal needs of influenza vaccine production.
  • *Level of role will be designated based on experience.


Major Accountabilities:
  • Perform real time batch record/logbook/document review concurrent with manufacturing, QC, or warehouse operations on the floor
  • Perform routine quality walkthroughs of site GMP facilities and operations
  • Act as the quality representative on the floor during troubleshooting and issue resolution. Escalate potential product or process related issues as needed.
  • Provide quality oversight of site critical alarm reports and corrective maintenance program
  • Support the development, revision and implementation of SOPs, batch records, protocols, and other GMP documents.
  • Perform QA activities related to change controls and deviations
  • Use computer systems to support the quality oversight of site operations such as: SAP, CMMS, TrackWise, GLIMS, Delta V, and BAS.
  • As needed, support greater FLQA organization in quality oversight of Fill/Finish, Utilities, and Maintenance operations.
  • Acquire and maintain knowledge of current local and international regulatory requirements/trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters are provided to the site.


Minimum Requirements:
  • Bachelor's degree in Science or equivalent experience in biotech or pharmaceutical industry.
  • Engineering discipline preferred.
  • Minimum 1+ years' experience; 3 years previous experience in a QA role supporting Bulk manufacturing or QC laboratory pharmaceutical operations or in a role within these organizations preferred.
  • Technical understanding of the production processes used in the pharmaceutical or biotechnology industry.
  • Previous experience in quality role in an FDA regulated manufacturing or laboratory setting or a strong understanding of the quality requirements for the pharmaceutical industry.
  • Strong organizational skills and ability to manage multiple tasks at one time.
  • Ability to follow assignments through to completion within defined timelines.
  • Strong communication skills, both written and oral.
  • Demonstrates risk based decision making.
  • Experience leading complex projects or teams.
  • Experience in root cause analysis, including working experience of root cause analysis tools such as fishbone/5Why.