Job Description

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Job Description

This position provides leadership over Plasma Quality Release operations and Lookback to ensure plasma availability for further processing.

The key area of responsibility is supervision of direct reports, including assignment of work activities and assurance of timely and compliant execution of tasks.

Additionally, the position is responsible for establishing performance metrics and reporting metrics to management.

Job Function and Description

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.
• Ensure Lookback/PDI Reference files are complete, accurate, maintained, and filed appropriately and meet all procedural requirements.
• Establish, prepare, and/or review trend data of various quality indicators and present trend data on a monthly and quarterly basis as required to managements.

Plasma Release:

• Monitor plasma availability/ inventory on shipment and disposition lot levels to ensure on-time plasma release according to goals and objective set for the department.
• Ensure destruction of unsuitable plasma units, as necessary, and ensure proper documentation; perform required system transactions.
• Communicate with quality, manufacturing, technical support groups, and plasma supplier staff to ensure availability of plasma and to resolve plasma-related discrepancies. Represent BioLife in meetings as required.
• Conduct process audits to ensure activities and documentation conform to standard operating procedures and regulatory requirements.
• Support, oversee, and participate in any quality related task pertaining to plasma, (i.e., visual inspection, cycle count, etc.) – will be performed in cold environment. Manage plasma holds based on support documentation and approvals. Support APDS configuration activities.
• Ensure all safety procedures/policies are followed, risk assessments are completed, and safety incidents are investigated within the timelines required.
• Act as Owner, Author, and Editor of departmental procedures and protocols, to ensure accuracy and compliance to company requirements and regulations. Review and approve SOP document changes as required.

Quality Systems:

• Perform quality review and approval of events in TrackWise for internal discrepancies associated with Plasma Quality Release and Plasma Operations processes and plasma supplier discrepancies; oversee investigations and approves corrective/preventive actions. May be required to act as event owner.
• Provide guidance to staff in order to ensure resolution of nonconformance (internal and supplier-related); mentor employees in investigation techniques and tools; conduct trend analysis of events and root causes. Participate in company Event Review Boards.
• Actively participate in internal/external audits as required and support the closure of audit observations within the specified timeframe.
• 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 purpose of presenting data, as required. Perform trending on a regular basis to identify opportunities for improvement.
• Initiate and execute requests for Change Controls.
• Give and remove access in User Management for APDS.

• Other duties as assigned

Other Job Requirements

• Must be able to lift, push, pull and carry up to 50 lbs.
• In general, 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.
• Must be able to sit for prolonged period of time.
• Must be able to support multiple shifts and/or work overtime.
• Some walking across the facility between various plasma management areas is necessary, including use of stairs.
• 5% travel may be required.

Leadership

• Manage direct reports by prioritizing work assignments, including special projects, routine and non-routine task, and assigning appropriate resources to each to ensure on-time execution of activities; control overtime spending.
• Establish training requirements for staff and monitor proficiency; maintain training/qualification on all tasks pertaining to plasma release.
• Manage departmental rotation of tasks to ensure proficiency of employees.
• Ensure development plans for self and direct reports are created, updated, and executed; provide coaching mentoring, and cross-training.
• Hold employees accountable; enforce company values/objectives and policies/procedures.
• Identify, lead, and implement continuous improvement initiatives.
• Work with Plasma Operations counterparts to ensure that key strategic objectives are met and ensure quality compliance to applicable procedures.

Decision-making and Autonomy

• Defines workflows as required for day-to-day plasma related activities and special projects and makes decisions on implementation.
• Make decisions pertaining to process improvements and implementation.
• Inform management of issues pertaining to process / personnel and execute mitigation or elimination plans.

Interaction

• Incumbent reports performance on a regular basis to management as required (Internal).
• Coordinates with Plasma Suppliers to resolve issues (Supplier).
• Coordinates with Plasma Operations and internal departments to resolve issues (Internal).
• Advises staff on the process and process related activities (Internal direct / indirect reports, including cross-trained personnel).

Innovation

• 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, GDDP, etc.) as they apply to Biologics.
• 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

• Resolves process and personnel related issues (direct reports).
• Makes scientifically sound and procedure driven decisions pertaining to identification, documentation, and resolution of any nonconformance's (internal / external).

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Essential

• Bachelor's degree.
• 5+ years of related experience.
• Or a combination of education and relevant work experience
• 3 years of experience in Quality Assurance / Quality Control or comparable industry experience.

Desired

• B.S in science, engineering or other related technical field
• 3-5 years of experience in Plasma/Whole Blood industry or biopharmaceutical industry desired.
• Experience in a leadership role is a plus.
• Green Belt Certification is a plus.

ADDITIONAL INFORMATION

• Proficient/intermediate knowledge of Microsoft Applications (Word, Excel, PowerPoint, and Visio); knowledge of computerized systems (e.g. APDS, JDE, DIS, LIMS, Trackwise, etc.) highly desirable.
• Must be detail oriented, have strong organizational skills, and the ability to prioritize workflow, handle multiple activities, and meet deadlines.
• Self-directed and motivated to complete repetitive tasks by following guidelines, procedure, and policies.
• Knowledge of FDA, PPTA, Good Manufacturing Practices, and Good Data Documentation Practices as they apply to plasma.
• Ability to identify errors or faults in the process using problem-solving tools (e.g. brainstorming, FMEA, etc.) and recommend and/or implement solutions.
• Demonstrate excellent communication skills (written and verbal). Utilize excellent grammar, mechanics, and proofreading skills to generate clear, concise, and accurate documentation (e.g. NCE, SCR, formal memorandums, email, etc.).
• Ability to diplomatically interact well with subordinates, coworkers, cross-functional team members, internal and external customers.
• Identify, promote, and develop business case for system improvements and process improvements; support implementation.

BioLife Compensation and Benefits Summary

For Location:

USA - GA - Social Circle - Baxter Pkwy

U.S. Base Salary Range:

$86,500.00 - $135,960.00

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

Yes