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Job Description

This role is responsible for reviewing documentation associated with plasma receipt and dispositioning, as well as release of acceptable plasma to production. Additional quality oversight is provided for Plasma Operations activities.

This position is also responsible for processing Post Donation (PDI) received from Plasma Suppliers and Testing Laboratories, to ensure the appropriate Category is assigned to the Notification/Observation and to ensure the plasma units in inventory are flagged for destruction.

Responsibilities

• Plasma Release
• 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.

• Lookback
• Process and/or verify Lookback/PDI Notifications/Observations received from plasma suppliers within the timeframe specified in department procedures and incompliance with regulatory requirements.

• Quality System
• Initiate Deviations in Trackwise 8 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.

• Other
• 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.
• Other duties as assigned

Education and Experience Requirements

         

Essential:

• BA / BS degree in Life Sciences and/or Business required or equivalent experience.
• Proficient/Intermediate knowledge of Microsoft Office (Word, Excel, Visio, and PowerPoint).

Desired:

• 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.

Key Skills, Abilities, and Competencies

Living our leadership behaviors is a basic expectation for all Takeda employees. Takeda expects all employees to embody the following:
 

Leadership Behaviors

• Integrity
• Fairness
• Honesty
• Perseverance

• Attention to detail.
• 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 repetitive tasks, with sensitivity to confidential information.
• Excellent writing skills and verbal communication skills.
• Ability to diplomatically interact well with coworkers, cross-functional team members, internal and external customers.
• Must be a team player.
• Ability to provide training and guidance to other team members.

Complexity and Problem Solving

• Ability to identify errors, non-conformances, or deficiencies and provide guidance.
• Identify faults/gaps in the process using problem-solving tools (e.g. Brainstorming, FMEA, etc.) and recommend and/or implement solutions.
• Communicate to management issues and recommend / proposing solutions.

Internal and External Contacts

• Ability to diplomatically interact well with coworkers, cross-functional team members, internal and external customers.
• Plasma Operations Group – provides quality oversight and advise.
• Plasma Suppliers and Service Providers – effectively communicate and work with suppliers to resolve any issues in a timely manner.
• BioLife HQ Quality Systems – coordinate activities pertaining to management of temperature excursions, supplier/service provider's discrepancies, advance notifications and other quality and logistics related activities.

Other Job Requirements

• Must be able to lift, push, pull and carry up to 50 lbs.
• The position requires a combination of sedentary work and walking around observing conditions in the facility.
• Must be able to work in cold temperature conditions ranging from -28°C-+8°C
• Must be able to wear special personal protective equipment required in cold environments over the head, face, hands, feet and body.
• Must be able to sit/stand for prolonged period of time.
• Some walking across the facility between various plasma management areas is necessary, including use of stairs.
• Must be able to work multiple shifts, including weekends.
• Must be able to work overtime as required.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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