Summary

CSL Limited is an Australian multinational specialty biotechnology company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions. Founded in 1916 as Commonwealth Serum Laboratories, CSL has grown to become the world's fifth largest biotechnology company with operations in over 35 countries. The company specializes in blood plasma derivatives, vaccines, antivenoms, and cell culture reagents used in medical and genetic research applications. CSL operates through several key divisions including CSL Behring (focusing on rare and serious diseases), CSL Seqirus (one of the world's largest influenza vaccine providers), CSL Plasma, and CSL Vifor. With over 32,000 employees globally, CSL maintains a strong R&D pipeline and has invested over US$3.3 billion in research and development over the past five years. The company is publicly traded on the Australian Securities Exchange and has its global headquarters in Parkville, Melbourne, Australia.

Job description

Responsibilities

Supports Assistant Manager in monitoring plasma center processes to ensure compliance with Standard Operating Procedures (SOPs) and applicable local, state and federal requirements
Ensures compliance to quality processes, regulatory requirements, SOPs and necessary training for plasma center and business operations
Coordinates training and facilitates processes to support timely reporting of biologic product deviations to the Food & Drug Administration (FDA)
Performs/ensures center records quality review to ensure thoroughness, accuracy and timeliness of required information
Initiates investigation to ensure documentation of deficiencies and development of corrective action plans, in partnership with management
Ensures training materials/documents are maintained and modified regularly; maintains the Learning Management System to ensure data integrity, report generation and data analysis
Conducts and may lead internal audits to monitor facility compliance with SOPs, cGMP, OSHA, FDA and other regulations, as applicable
Collaborates with center management in the development and implementation of continuous improvement plans

Qualifications

Bachelor's/Associate degree in business administration or biological sciences preferred, or equivalent combination of education, training and experience
3-5 years' quality or regulatory affairs experience in Plasma or related industry
Minimum of 1-year leadership experience or equivalent of one-year experience in a regulated environment
Knowledge of cGMP, OSHA, FDA and other applicable regulations
Strong customer service skills
Equivalent combination of education and professional work experience required

Requirements

Bachelor's/Associate degree in business administration or biological sciences preferred, or equivalent combination of education, training and experience
3-5 years' quality or regulatory affairs experience in Plasma or related industry
Minimum of 1-year leadership experience or equivalent of one-year experience in a regulated environment
Knowledge of cGMP, OSHA, FDA and other applicable regulations
Strong customer service skills
Equivalent combination of education and professional work experience required

Company overview

CSL Limited is an Australian multinational specialty biotechnology company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions. Founded in 1916 as Commonwealth Serum Laboratories, CSL has grown to become the world's fifth largest biotechnology company with operations in over 35 countries. The company specializes in blood plasma derivatives, vaccines, antivenoms, and cell culture reagents used in medical and genetic research applications. CSL operates through several key divisions including CSL Behring (focusing on rare and serious diseases), CSL Seqirus (one of the world's largest influenza vaccine providers), CSL Plasma, and CSL Vifor. With over 32,000 employees globally, CSL maintains a strong R&D pipeline and has invested over US$3.3 billion in research and development over the past five years. The company is publicly traded on the Australian Securities Exchange and has its global headquarters in Parkville, Melbourne, Australia.