Quality Specialist

Mishawaka, IN - USA

Monthly Salary: Not Disclosed

Posted on: 5 hours ago

Vacancies: 1 Vacancy

Job Summary

Responsibilities:

Under general direction monitors plasma center processes to ensure compliance with Standard Operating Procedures (SOPs) and applicable local state and federal requirements
Partners with management to have the center inspection ready at all times by managing compliance to SOPs and the quality system
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 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
Leads internal audits to monitor facility compliance with SOPs cGMP OHSA FDA and other regulations as applicable

Qualifications:

Must be able to work a flexible schedule including every other Saturday
Bachelors/Associate degree in business administration or biological sciences preferred or equivalent combination of education training and experience
3-5 years experience in quality within Plasma or related industry
Minimum 1-year supervisory/leadership experience or equivalent of 1-year experience in a regulated environment
Knowledge of cGMP OHSA FDA and other applicable regulations
Strong customer service skills
Equivalent combination of education and professional work experience required

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

About CSLPlasma

CSL Plasma operates one of the worlds largest and most sophisticated plasma collection networkswith over 350 plasma collection centers in the U.S. Europe and China. Headquartered in Boca Raton Florida CSL Plasma is a subsidiary ofCSL Behring a global biotherapeutics business and a member of CSL. Plasma collected at CSL Plasma facilities is used by CSL Behring for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent companyCSLheadquartered in Melbourne Australia employs 32000 people.

Learn more about CSL Plasma here and CSL CSL Behring CSL Seqirus and CSL Vifor here more about CSL CSL Behring CSL Seqirus and CSL Vifor here at and CSL Plasma at Benefits

For more information on CSL Plasma benefits visit Belong at CSL

At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future.

To learn more visit Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process please visit Experience:

Responsibilities:Under general direction monitors plasma center processes to ensure compliance with Standard Operating Procedures (SOPs) and applicable local state and federal requirementsPartners with management to have the center inspection ready at all times by managing compliance to SOPs and the...