Quality Rep

About the role

BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. This role focuses on ensuring that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations.

Responsibilities

• 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.

Qualifications

• 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)

Skills

• Technical/Functional (Line) Expertise: Maintains general cleanliness of work area and assists other work areas as needed to ensure a clean and professional environment. Production environment oversight.

Benefits

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.