Specialist I QA Operations

United States of AmericaR-1076162010 CSL Behring L.L.C.

About CSL

With operations in 35+ nations and ~ 22,000 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 the second largest influenza vaccine company 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

Responsible for assisting with investigating deviations, relevant to area of responsibility. Responsible for driving continuous improvement on production floor to ensure compliance to cGMPs. Real time review of batch records, including critical processing steps with production floor presence.

Responsibilities and Accountabilities:
1 Responsible for assisting with investigating deviations relevant to area of responsibility.
2 Responsible for participating in investigation meetings with responsible department and any required support group(s).
3 Responsible for participating in necessary research to determine root cause, corrective/preventative actions, product disposition, and using the investigation tools provided by QAO Management.
4 Collaborate with manufacturing personnel to perform root cause analysis at time deviation occurs, and assist in determining robust corrective/preventive actions.
5 On-call for immediate inspections, investigations and review of possible GMP related issues and ability to provide quality assessment of potential deviation.
6 Responsible for real-time review of critical in-process steps (e.g. viral reduction / sterility assurance), review/approval of completed production records, and providing immediate notification to manufacturing personnel (e.g. supervisors/operators) regarding facility/ process /equipment /documentation issues.
7 Execute training/awareness related to investigation and GMP changes to production personnel.
8 Drive continuous improvement on production floor to ensure compliance to cGMPs.
9 As appropriate to area of responsibility, responsible for ensuring sample retain area is maintained in a state of compliance and all annual inspections are completed in a timely manner.
10 As appropriate to area of responsibility, perform Acceptable Quality Level (AQL) assessments.


Education
B.A. or B.S. degree preferably in scientific or technical field (e.g., chemistry, biology, physics, engineering, computer science, technical writing).

Experience
0-2 years’ experience working in a cGMP regulated environment such as the field of quality,
manufacturing or engineering field, applying the cGMP rules in everyday activities. Technical
writing experience is preferred.

Competencies
Informing – is timely and accurate with information.
Peer Relationships – Can quickly find common ground and solve problems for the good of all, is a team player and cooperative.
Self-Knowledge – Seeks feedback, gains insights from mistakes, is open to criticism.
Action Oriented - Enjoys working hard; is energetic for the things that he/she sees as
challenging.
Written Communications – is able to write clearly in a variety of communication settings and
styles, can get messages across
Conflict Management – Steps up to conflicts, seeing them as opportunities, can find common
ground.
Learning on the Fly – Open to change, learns quickly when facing new problems, versatile
learner.
Dealing with Ambiguity – Can effectively cope with change, can shift gears comfortably, can
comfortably handle risk and ambiguity.

Additional Comments:
Must demonstrate competency in verbal and written communication. TrackWise knowledge a
plus.