Specialist I/II/III, QA (Front Line)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Oct 10, 2020
Ref
R-123488
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 manufacturing (bulk, sterile formulation/filling, and packaging), laboratories, utilities, maintenance, and logistics . Core responsibilities of this role include quality walkthroughs on the floor, GMP record reviews and approvals, log book review, and real time triage of quality related issues.

  • Shift: Days
  • Monday -Friday
  • Level will be determined by years of experience


Major Accountabilities:

  • Responsible for maintaining audit program, reviewing functional and release documentation and investigating deviations relevant to area of responsibility.
  • Reviews lot release documentation and facilitates compliant release process for corresponding market.
  • Responds to questions from regulatory authorities to ensure timely product release.
  • Ensures standard operating procedures (SOP's) stay current and align with corporate and regulatory requirements.
  • Executes training/awareness related to GMP standards.
  • T roubleshoots issues that occur during the manufacturing of product on shift.

Minimum Qualifications:


  • University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry.)
  • Minimum of 1year of GMP experience in pharmaceutical/biotech or other regulated industry. 3 years preferred.
  • Knowledge of current Good Manufacturing Practices (cGMP) principles.
  • Knowledge of FDA and EMA requirements.