Melissa Pospisil
Dover,OH
Summary
Qualified Quality professional with solid background in ensuring compliance and supporting efficient operations. Demonstrates strong analytical, communication, and teamwork skills, with proven ability to quickly adapt to new challenges. Effective at prioritizing tasks and meeting deadlines. Thorough team contributor with strong organizational capabilities.
Overview
10
10
years of professional experience
Work History
Quality Systems Associate
Grifols
10.2017 - Current
- Oversees Plasma Product Quality and Donor Safety center operations
- Facilitates cross-functional teams ensuring compliance to company protocols, cGMP, regulatory requirements, and SOPs
- Interprets procedural changes, assesses impact on staff, and works with Area Leads on mitigating risks and seamless integration
- Coordinates and drives staff training for approximately 30 employees for continuous development through LMS applications and monitors schedules to alleviate overdue compliance
- Performs direct observations across 4 process areas to identify and rectify sources of quality deviation
- Trained 4 prospective Quality staff on Quality Systems management
- Investigates, documents, implements, and monitors CAPA associated with non-conforming events and performs monthly trend analysis utilizing Trackwise error management software
- Leads cross-functional meetings by conveying quality concerns and coordinates improvement initiatives
- Maintains and reviews records including calibration certifications, employee credentials / licenses, training reports, and equipment validation reports ensuring audit readiness
- Facilitates training sessions for new employees, ensuring smooth onboarding process
- Hosts internal and external regulatory agencies (ie. EMA, FDA, health department) and composes audit responses
- Evaluates repairs of out-of-range calibrated equipment and finalizes approval for use
- Inspects and releases incoming softgood supplies for procedural use and manages defective reporting
- Audits donor processing and plasmapheresis event documentation for accuracy and compliance
- Manages plasma sample viral test results and facilitates discussion with laboratory personnel in determination of product suitability
- Coordinates and executes biweekly plasma product shipment and release for pharmaceutical manufacturing
- Achieves consistent top Quality Metrics scores for compliant industry standards for the past 3 years
- Recognized as a top performing employee in Quality Achievement and contributed to the center’s receipt of the Plasma Procurement Excellence Award given in Barcelona, Spain
Regulatory and Quality Affairs Associate
Henry Schein Animal Health
06.2015 - 05.2017
- Directed operations employees within 12 distribution centers on product recall processing
- Tracked recall correspondence and provide recall expenses and directions to suppliers
- Verified supplier documentation and entry to ensure FDA compliance of pharmaceutical products
- Organized cross-functional teams to improve internal processes and developed 3 SOPs
- Fielded customer complaints and followed up with direct correspondence based on leads submitted by sales department
Education
Bachelor of Science - Biology, Education
The Ohio State University
Columbus, Ohio01-2013
Skills
- Detail-focused
- Self-driven
- Internal auditing
- Excellent interpersonal and coaching skills
- Effective problem solving
- Efficient report writing and management
- Extensive experience working individually and on a team
- Functional knowledge of regulatory compliance and quality control
Timeline
Quality Systems Associate
Grifols
10.2017 - Current
Regulatory and Quality Affairs Associate
Henry Schein Animal Health
06.2015 - 05.2017
Bachelor of Science - Biology, Education
The Ohio State University
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