Quality Rep

Overview

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Job Description

About Bio Life Plasma Services

Every day at Bio Life, 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.

Bio Life Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.

• 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 SOPs 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.

Education, Behavioural Competencies And Skills

Essential: High School Diploma or equivalent required.

Desired: Associates or Bachelor's degree highly desirable.

FLSA Classification (US) - Exempt

Other Duties And Responsibilities As Assigned.

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.

USA - MA - Worcester

$73,600.00 - $

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.

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