Quality Specialist

CSL Plasma; City of Rochester (NY); On-site; USD 32,000 - 35,000; Full time

Job summary

CSL Plasma is seeking a Quality Assurance professional to monitor plasma center processes and ensure SOP compliance with applicable local, state, and federal requirements. You will partner with management to keep the center inspection-ready at all times by enforcing the quality system and procedures.

The role requires 3–5 years of plasma quality experience, 1+ year of supervisory work, and strong knowledge of cGMP, OSHA, and FDA regulations.

Qualifications

• 3-5 years' quality experience in Plasma or related industry
• Minimum 1-year supervisory/leadership experience or equivalent
• Knowledge of cGMP, OHSA, FDA, and related regulations
• Bachelor's/Associate degree in business administration or biological sciences preferred
• Strong customer service skills

Responsibilities

• Monitors plasma center processes to ensure SOP and regulatory compliance
• Partners with management to maintain inspection readiness by enforcing SOPs and quality systems
• Ensures compliance with quality processes and training requirements
• Coordinates training and facilitates timely reporting of deviations to FDA
• Performs center records quality review for thoroughness and timeliness
• Initiates investigations and develops corrective action plans with management
• Maintains LMS data integrity and generates reports
• Leads internal audits to monitor compliance with SOPs, cGMP, OSHA, FDA and other regs

Skills

Quality management

Regulatory knowledge

Leadership

SOP compliance

Attention to detail

Education

Bachelor's/Associate degree in business or biology

Tools

Learning Management System

Job description

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

• Bachelor's/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.

The expected base pay for this position at hiring is $23.04/hour - $25.15/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.