Quality Specialist

CSL; Edison (NJ); On-site; USD 36,000 - 40,000; Full time

Job summary

CSL is seeking a QA/Regulatory Associate in Edison, NJ to support plasma center compliance and continuous improvement. You will help monitor processes, ensure SOP adherence, and coordinate training across operations while maintaining quality records and timely deviations reporting.

The role requires knowledge of cGMP, OSHA, FDA regulations, and strong customer service skills, with 3–5 years in a regulated plasma setting and leadership experience. On-site position with competitive hourly pay.

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.

Responsibilities

• Supports Assistant Manager in monitoring plasma center processes to ensure SOPs and regulatory requirements are followed.
• Ensures compliance to quality processes, regulatory requirements, SOPs and trainings for plasma center and business operations.
• Coordinates training and reporting of biologic product deviations to FDA.
• Performs center records quality review for accuracy and timeliness.
• Initiates investigations to document deficiencies and develop corrective actions with management.
• Maintains Learning Management System and data integrity for reporting and analysis.
• Conducts internal audits to monitor compliance with SOPs, cGMP, OSHA, FDA and other regulations.
• Collaborates with center management on continuous improvement plans.

Skills

Leadership experience

Regulatory affairs

Quality processes

Customer service

Education

Bachelor's/Associate degree in business administration or biological sciences

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, 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.