Octapharma Plasma, Inc. · 1 month ago
Center Quality Manager 1
Maple Heights, OH
Full-time
Onsite
Entry Level
1+ years expOctapharma Plasma, Inc. is a company focused on plasma collection and product quality. The Center Quality Manager will ensure compliance with regulatory requirements and oversee quality control processes while collaborating with the Operations team to maintain product quality and donor safety.
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
One (1) year experience in a Quality Assurance role required
Preferred
B.S. degree preferred. Other combinations of education and experience may be considered
Experience with quality management systems (QMS) and quality control processes preferred
Benefits
Formal training
Outstanding plans for medical, dental, and vision insurance
Health savings account (HSA)
Flexible spending account (FSA)
Tuition Reimbursement
Employee assistance program (EAP)
Wellness program
401k retirement plan
Paid time off
Company paid holidays
Personal time
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
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2025-09-26
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