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Job Description
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.
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 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
Technical/Functional (Line) Expertise
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.
Leadership
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
Critical Skills
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
Interaction
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.
Complexity
Ability to identify errors, non-conformances, or deficiencies and provide guidance to Plasma Operations and Plasma Quality Release.
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.
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.
ADDITIONAL INFORMATION
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.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. W e are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - GA - Social Circle - Baxter Pkwy
U.S. Hourly Wage Range:
$20.53 - $32.26
The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained , certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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.
Locations
USA - GA - Social Circle - Baxter Pkwy
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
No
