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Center Quality Manager I at Octapharma Plasma Inc

Chicago, IL 60643, USA -

Full Time

Start Date

Immediate

Expiry Date

07 Nov, 25

Salary

0.0

Posted On

07 Aug, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Vision Insurance, Leadership

Industry

Pharmaceuticals

Description

How To Apply:

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Responsibilities

Operate independent of plasma center Operations to ensure compliance with all applicable federal, state, and local regulations, as well as industry standards (e.g., FDA, EMA).
Reports critical incidents and negative trends to plasma center Operations team and Regional Quality Director.
Collaborate with the plasma center Operations team 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 regulatory requirements.
Oversee the quality control processes, including donor screening, plasma collection, storage, and shipping.
Monitor and review quality performance indicators, including deviations, CAPAs (Corrective and Preventive Actions), and complaints.
Perform final QA review and release for all product shipments and associated documents to ensure shipment meets customer specifications.
Ensure:
Quality Control (QC) checks and validation activities are performed in accordance with SOP.
Equipment maintenance and calibration documentation comply with Standard Operating Procedures (SOPs).
Proficiency surveys and CLIA-required competency assessments are performed in accordance with the required timeframes defined in SOP.
Prepare agenda and lead monthly Quality Assurance Meeting to discuss SOP changes and regulatory requirements are conducted, documented and minutes are communicated to all donor center staff.
Serve as Designated QA Trainer.
Prepare for and lead internal and external audits and inspections.
Perform root cause analysis, implement corrective/preventive actions, and conduct effectiveness checks for systemic issues.
Continuously assess, promote, and improve the effectiveness of the quality systems in the plasma center through the investigation of trends resulting from failures in the execution of procedures.