BioLife Quality Representative
Company: Biolife Plasma Services
Location: Egg Harbor City
Posted on: May 7, 2022
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information I provide in my application will be processed in line
that all information I submit in my employment application is true
to the best of my knowledge.Job DescriptionAbout BioLife Plasma
ServicesEvery day at BioLife, we feel good knowing that what we do
helps improve the lives of patients with rare diseases. While you
focus on our donors, we'll support you. We offer a purpose you can
believe in, a team you can count on, opportunities for career
growth, and a comprehensive benefits program, all in a fast-paced,
friendly environment.BioLife Plasma Services is a subsidiary of
Takeda Pharmaceutical Company Ltd.OBJECTIVES/PURPOSEMonitors all
systems and activities to ensure that source plasma manufacturing
is performed consistently according to current Good Manufacturing
Practices (cGMP), the Shire Quality System, and other applicable
regulations for a plasma center. Authorized and responsible to
cease operations within the center or stop source plasma
shipment(s) if product or donor safety is or may be compromised.All
below listed responsibilities must be completed in compliance with
federal, state, local and company-specific regulations related to
quality of product, employee and donor safety, and to the proper
performance of day-to-day activities. Employees must also maintain
complete and accurate records, in accordance with
- Regulatory Compliance: (15%)
- Stays current with federal, state, local and company-specific
rules, regulations, and practices.
- Ensures center compliance with all federal, state, local and
company-specific regulations related to quality of product,
employee and donor safety.
- Ensures that SOP's are current and that staff perform routine
tasks according to SOP through direct observation.
- Plasma Collection Center Quality Assurance Oversight: (80%)
- Reviews operational records to ensure they are complete,
accurate and compliant with cGMP requirements.
- Tracks deviations and trending in operating procedures and
policies through established mechanisms. Reports errors,
deficiencies, discrepancies and observations to center management
and the Regional Quality Manager. May stop operations or shipments
when donor or product safety is or may be compromised.
- Identifies potential SOP revisions as needed to support
- Works in collaboration with center manager and management team
to prepare for and host (if needed) internal auditors and external
inspectors. Assists center management teams to ensure timely
closure of audit observations.
- Tracks responses to and evaluates effectiveness of corrective
actions for errors.
- Conducts monthly quality assurance audits for critical control
points and key elements for the systems related to donor
suitability, source plasma collection, sample collection, plasma
storage, product release, quality assurance, and employee training
- Coordinates management review meetings and participates in
center staff meetings.
- Employee Recruitment and Retention: (5%)
- Responsible for providing feedback and developing employees in
the quality department. Provides feedback during the recruitment
process for quality department employees, including performance
evaluations and merit increases.
- Fosters teamwork. Works collaboratively with staff, peers, and
management to achieve business goals. Communicates continuously and
resolves conflicts proactively.
- Provides timely feedback on performance and initiates
disciplinary action when necessary.
- Participates in the evaluation and review of center staff.
- Ensures high levels of customer service and satisfaction. Meets
and strives to exceed customer expectations.DIMENSIONS AND
ASPECTSTechnical/Functional (Line) Expertise
- Minimum of one-year relevant work experience, or an equivalent
combination of education and experience. Relevant work experience
within medical or regulated field, highly desirable.
- Previous work experience within the plasma collection industry
is strongly preferred.
- Computer skills in word processing, excel, data analysis and
databases highly desirable.
- Demonstrated understanding of quality assurance in an
- Demonstrated understanding of plasma center operations.
- Effective organizational, technical and problem-solving
- Putting the patient at the center
- Building trust with society
- Reinforcing our reputation
- Developing the businessDecision-making and Autonomy
- Responsible for providing exceptional customer service to
donors (external) and fellow employees (internal)
- Refers to Group/Regional Lead for guidance on complex,
high-impact or urgent decisions (internal)
- Refers to management team for escalated donor/employee concerns
- Consults and coordinates directly with the Center Manager on
quality concerns within the plasma center.
- Advises and coordinates will all other center roles to
effectively problem solve, mitigate risk, ensure safety of staff
and donors, and provide an exceptional customer experience.
- Attend staff meetings and other team meetings as required.
- Attention to detail and ability to work independently
- Effective coaching and counseling skills.Innovation
- May participate in the management of projects and new
initiatives within the center or across centers.
- Coordinates will all other center roles to effectively problem
solve, ensure safety of staff and donors, and provide an
exceptional customer experience.
- Supports the center management team in identifying operational
opportunities for continuous improvement, initiating changes to
center processes as needed, through use of company approved
procedures (including but not limited to 5S, Value Stream Mapping
- Maintain general cleanliness of work area and assist other work
areas as needed to ensure a clean and professional
- Production environment oversight.EDUCATION, BEHAVIOURAL
COMPETENCIES AND SKILLS:Essential: High School Diploma or
equivalent required.Desired: Associates or Bachelor's degree highly
- FLSA Classification (US) - Exempt
- Other duties and responsibilities as assigned.EEO
StatementTakeda 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.LocationsUSA - NJ - Egg HarborWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Biolife Plasma Services, Camden , BioLife Quality Representative, Other , Egg Harbor City, New Jersey
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