Quality Coordinator – Plasma Quality Release – Evening Shift

Quality Coordinator – Plasma Quality Release – Evening Shift

Requirements

• Must possess effective interpersonal, communication, leadership, influencing, and negotiating skills to interact with all laboratories and suppliers on a frequent basis.
• Strong knowledge and understanding of applicable regulatory and quality requirements and standards.
• Must be able to write concisely and clearly.
• Ability to articulate clearly and conduct oral presentations.
• Attention to detail and organizational skills with analytical and problem-solving skills.
• Proficiency in the use of personal computers and software programs including Microsoft Word, Excel and PowerPoint.
• Result-oriented with the ability to adapt to changing priorities.
• Demonstrated ability to convey technical information to others.
• Must have the ability to act as a change agent to identify and implement solutions as well as effectively lead and motivate team members to achieve team goals.
• Strong organizational skills and the ability to prioritize workflow, handle multiple activities, and meet deadlines as set.
• Ability to complete tasks by following guidelines, procedures and policies.
• Knowledge of FDA Regulations (cGMP, GDP, etc.) as they apply to Biologics.
• Self-directed and motivated to complete complex tasks and make quality decisions.

Responsibilities

• Review documentation associated with plasma dispositioning and perform quality review and release for plasma to be used in Teardown in the Automated Plasma Dispositioning System (APDS).
• Review shipment documentation associated with plasma shipments received and perform quality review in the Automated Plasma Dispositioning System (APDS).
• Ensure destruction of unsuitable plasma units, as necessary and ensure proper documentation: perform required system transactions.
• Place shipments and plasma centers on hold and remove holds based on sufficient support documentation and approvals.
• Process and/or verify Lookback/PDI Notifications/Observations received from plasma suppliers within the timeframe specified in department procedures and incompliance with regulatory requirements.
• Initiate Deviations in Trackwise for internal discrepancies associated with Plasma Quality Release and Plasma Operations processes and for plasma supplier discrepancies; conduct investigations and identify corrective/preventative actions.
• Review and ensure discrepancies are documented, investigated, and resolved using the appropriate PQR Quality System according to set deadlines.
• Revise department owned procedures for compliance with Corporate, BioLife, and Regulatory requirements and implementation of continuous improvement initiatives as required.
• Utilize excellent grammar, mechanics and proofreading skills to generate clear, concise, and accurate documentation (e.g. NCE, Deviations, SCAR formal memorandums, electronic mail, etc.).
• Conduct process audits to ensure activities and documentation conform to standard operating procedures and regulatory requirements.
• File documentation according to procedural requirements and ensure retention policies are met.
• Identify, lead and implement continuous improvement projects.
• Actively participate in internal or external audits as required (e.g. runner, communication flow, document reviewer, etc.) and support the closure of audit observations within the specified timeframe.
• Support special projects / protocols execution.
• Identify and inform PQR Management of plasma related discrepancies.
• Communicate with quality, manufacturing, technical support groups, and plasma supplier staff to ensure availability of plasma and to resolve plasma related discrepancies.
• Provide and present to management monthly statistical data for key metrics, such as plasma receipts, plasma on hold and other key information. Create and present PowerPoint slides for the purposes of presenting data, as required.

Preferred Qualifications

• 2 – 4 years of experience in Plasma / Whole Blood Industry or Biopharmaceutical / Biotech.
• 1 – 2 years of experience in the quality organization.
• Knowledge of computerized systems (e.g. APDS, TrackWise, C3ME, LIMS) or other inventory management or quality systems software.