Octapharma Plasma, Inc. · 9 hours ago
Center Quality Manager 1
North Charleston, SC
Full-time
Onsite
Entry Level
1+ years expOctapharma Plasma, Inc. is a company focused on enhancing lives and careers through strong growth and development opportunities. They are seeking a Center Quality Manager 1 to ensure compliance with regulations, oversee quality control processes, and lead quality assurance initiatives at their donation centers.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Operate independently of plasma center operations to ensure compliance with all federal, state, local, and industry regulations (e.g., FDA, EMA)
Report critical incidents and negative trends to the Operations team and Regional leadership and collaborate with Operations to ensure product quality and donor safety
Maintain current knowledge of regulations and standards affecting plasma collection and donor safety; execute QA policies and procedures to comply with requirements
Oversee quality control processes, including donor screening, plasma collection, storage, and shipping; ensure QC checks, validations, equipment calibration, and CLIA assessments are performed according to SOPs
Monitor and review quality performance indicators, including deviations, Corrective and Preventive Actions (CAPAs), and complaints; lead monthly Quality Assurance meetings to discuss SOP changes and regulatory requirements
Conduct final QA review and release of all product shipments and associated documents to ensure compliance with customer specifications
Serve as Designated QA Trainer, developing and delivering training on GMP, SOPs, and compliance; provide direction and oversight to Quality backup staff and participate in QA staff selection
Prepare for and lead internal and external audits; maintain audit records and ensure timely completion of audit responses and corrective actions
Perform root cause analyses, implement CAPAs, and conduct effectiveness checks for systemic issues
Continuously assess, promote, and improve quality systems by investigating trends, supporting continuous improvement initiatives, and monitoring outcomes
Provide leadership in the implementation of changes, adjusting strategies as necessary to strengthen quality and compliance
Perform other duties as assigned
Qualification
Required
Operate independently of plasma center operations to ensure compliance with all federal, state, local, and industry regulations (e.g., FDA, EMA)
Report critical incidents and negative trends to the Operations team and Regional leadership and collaborate with Operations to ensure product quality and donor safety
Maintain current knowledge of regulations and standards affecting plasma collection and donor safety; execute QA policies and procedures to comply with requirements
Oversee quality control processes, including donor screening, plasma collection, storage, and shipping; ensure QC checks, validations, equipment calibration, and CLIA assessments are performed according to SOPs
Monitor and review quality performance indicators, including deviations, Corrective and Preventive Actions (CAPAs), and complaints; lead monthly Quality Assurance meetings to discuss SOP changes and regulatory requirements
Conduct final QA review and release of all product shipments and associated documents to ensure compliance with customer specifications
Serve as Designated QA Trainer, developing and delivering training on GMP, SOPs, and compliance; provide direction and oversight to Quality backup staff and participate in QA staff selection
Prepare for and lead internal and external audits; maintain audit records and ensure timely completion of audit responses and corrective actions
Perform root cause analyses, implement CAPAs, and conduct effectiveness checks for systemic issues
Continuously assess, promote, and improve quality systems by investigating trends, supporting continuous improvement initiatives, and monitoring outcomes
Provide leadership in the implementation of changes, adjusting strategies as necessary to strengthen quality and compliance
Ability to work day and evening hours, weekends, holidays, and extended shifts
Ability to sit or stand for extended periods for up to four (4) hours at a time
Ability to tug, lift, and pull up to thirty-five (35) pounds
Ability to bend, stoop or kneel
Ability to enter an environment with a temperature of -40°C for short periods of time
Occupational exposure to blood borne pathogens
Ability to view video display terminal less than 18” away from face for extended periods of time, up to four (4) hours at a time
Ability to perform precise tasks that require repetitive small motor skills, such as drawing blood for diagnostic tests
Ability to type and use basic computer skills
Ability to use assistive devices if needed for mobility or communication
Preferred
Bachelor's degree preferred
One (1) year experience in a Quality Assurance role
Experience with quality management systems (QMS) and quality control processes preferred
Company
Octapharma Plasma, Inc.
About Us: Octapharma Plasma, Inc. helps change lives through the incredible power of plasma donation.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Judy Smith
COO and EVP
Barry Pomeroy
Vice President - Finance
Recent News
Talk Business & Politics
2025-09-26
Company data provided by crunchbase