What are the responsibilities and job description for the Quality Specialist position at CSL Plasma?
Entity: CSL Plasma
Job Category: Quality
Job Family: Plasma Center
Job Type: Full Time
Location: Edison, New Jersey, United States
Employer Reference: R-294435
Job Description
- 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, 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.
The expected base pay for this position at hiring is $26.33/hour - $28.74/hour. Please note this wage range reflects what CSL expects to pay for this position at the listed location as of the time of this posting. Individual base pay for a successful candidate within this range is determined by qualifications, skill level, experience, competencies and other relevant factors.
About CSL Plasma
CSL Plasma operates one of the world's largest and most sophisticated plasma donation networks, with nearly 330 donation centers in the U.S. and Europe. CSL Plasma is a subsidiary of CSL, a global biopharma company. Plasma collected at CSL Plasma facilities is used by CSL for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent company, CSL (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs 29,000 people. For more information about CSL Plasma visit, https://www.cslplasma.com/.
Our Benefits
For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp.
You 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 https://www.csl.com/careers/inclusion-and-belonging
Equal 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 https://www.csl.com/accessibility-statement.
Benefits:
401K Plan, Vacation & Paid Time Off, Health InsuranceSalary : $26 - $29