Specialist II QA Operations

Employer
CSL Behring
Location
Kankakee, Illinois
Posted
Nov 27, 2021
Ref
R-144017
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
Job Description

Provides oversight for development and maintenance of quality programs, systems, processes and procedures to ensure compliance with company standards and regulatory guidelines. Leads preparation for audits/inspections and resolution of findings; liaises with auditing groups and inspectors throughout audits. Coordinates legal requests in support of government investigations or litigations. Ensures quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide, sharing of best practices, and achievement of the company's mission globally.

Responsibilities

  • Under direct supervision, supports Quality Assurance activities to ensure compliancewith company and cGMP standards

  • Participates in investigation meetings with responsible department and any requiredsupport group(s)

  • Performs inspections and maintains quality records for analysis of raw materials,materials in process, and finished products

  • May conduct internal audits including audits of regulatory submissions

  • Assists in preparation for regulatory and customer inspections and participates ininspections to ensure quality standards

  • Executes training/awareness related to investigation and GMP changes to production team

Qualifications

  • Bachelor degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology,Biochemistry)

  • 0-2 years’ experience working in a cGMP regulated environment

About Us

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.

Do work that matters at CSL Behring!