Investigation Owner, Quality Control

Employer
CSL Behring
Location
Kankakee, Illinois
Posted
Jun 25, 2021
Ref
R-137043
Discipline
Quality, Quality Control
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time

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

Responsibilities:
•    Writing investigating deviations, relevant to area of responsibility.
•    Responsible for organizing / leading investigations, determining root cause,
corrective/preventative actions and product disposition.
•    Collaborate with manufacturing personnel to perform root cause analysis at time deviation occurs, and assist in determining robust corrective/preventive actions.
•    Responsible for performing complete and accurate deviation investigations in accordance with site procedures/metrics while meeting DIFOT.
•    Responsible for contact with other CSL sites when necessary for investigations and/or changes.
•    On-call for immediate inspections, investigations and review of possible GMP related issues and ability to provide sound quality decisions of potential impact to product
•    Execute training/awareness related to GMP changes to production personnel.
•    Assist in regulatory inspections as requested by management.
•    Confirmation of QAO initial risk assessments and day one investigation reports 
•    Facilitating investigations 
•    Gathering data for investigations
•    Facilitating Root Cause Analysis and CAPA determination
•    Writing investigation and including supporting documentation. 
•    Creation of CAPA records in EQMS system. 
•    Conducting searches in EQMS to identify trends/re-occurrences
•    Conducting past CAPA searches to identify repeat CAPAs
•    Collaboration with QAO for SQuIPP impact and investigation robustness. 
•    Creating extension supplements every 15 days for all overdue investigations.
•    OOT investigation ownership including assigning assessments to Metrology and responsible area
•    Resolving batch holds in EQMS system. 
•    Writing assessments for PTC investigations to support IQA.
•    Assist QC for CAPA creation in EQMS related to lab error OOX investigations. 
•    Deviation tracking and metric reporting weekly

Qualifications:
• Bachelor degree in a relevant scientific discipline (Biology, Microbiology, Chemistry, etc.)
• 3+ years' lab experience