Quality Specialist

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

Job summary

CSL Plasma in Edison, NJ is seeking a Regulatory Affairs/Quality Specialist to support monitoring plasma center processes and ensure SOP compliance with local, state, and federal requirements. You will coordinate training and assist in reporting deviations to the FDA, while maintaining GMP standards and training records.

The role requires 3–5 years in quality or regulatory affairs in plasma or related industries, plus leadership experience or equivalent in a regulated setting.

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.

Responsibilities

• Supports Assistant Manager in monitoring plasma center processes to ensure compliance with SOPs and 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 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.

Skills

Customer service

Education

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

Education/training equivalent

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.