Quality Management Rep
Takeda
Indianapolis, Indiana
Full-Time
$63,080
HybridManager
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About BioLife Plasma Services
Every 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/PURPOSE
Monitors 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 cGMP.
ACCOUNTABILITIES
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 continuous improvement.
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 program.
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 ASPECTS
Technical/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 FDA-regulated environment.
Demonstrated understanding of plasma center operations.
Effective organizational, technical and problem-solving skills.
Leadership
Integrity
Fairness
Honesty
Perseverance
Putting the patient at the center
Building trust with society
Reinforcing our reputation
Developing the business
Decision-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 (internal)
Interaction
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 and Kaizen).
Complexity
Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment.
Production environment oversight.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Essential: High School Diploma or equivalent required.
Desired: Associates or Bachelor’s degree highly desirable.
ADDITIONAL INFORMATION
FLSA Classification (US) - Exempt
Other duties and responsibilities as assigned.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - IN - IndianapolisU.S. Base Salary Range:
$63,080.00 - $86,735.00
The estimated salary range reflects an anticipated range for this position. The actual base salary 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 base salary 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 and/or long-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.
Job Exempt
Yes