Quality Lead Technician

About the role

BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. Our objectives are to monitor and ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations. We aim to support our donors while maintaining a safe and efficient environment for our staff and donors.

Responsibilities

• Reviews operational records in association with tasks trained and assigned to ensure they are complete, accurate and compliant with cGMP requirements.
• Tracks deviations in operating procedures and policies through established mechanisms.
• Reports error, deficiencies, discrepancies and observations to center management and Quality Management Representative (QMR).
• 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.
• Ensures SOP’s are current and that staff perform routine tasks according to SOP through direct observation.
• Works in collaboration with the management team to prepare for and host (if needed) internal auditors and external inspectors.
• Aids center management teams to ensure timely closure of observations.
• Maintain qualifications and perform all duties (core and elective) for Medical History, Phlebotomy, and Sample Processing areas.
• Train new and existing staff on donor center procedures through demonstration, instruction, observation, and feedback.
• Provide leadership and training assistance in support of center management and supervisory team, including oversight of operational flow.
• Maintain certification and perform all required duties of Lead Technician.
• Ensure all tasks are performed 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.
• Maintain complete and accurate records in accordance with cGMP.

Qualifications

• A minimum of one year of relevant work experience, preferably in a regulated industry, or an equivalent combination of education and experience.
• Certification in all three primary operational areas of the plasma center (Medical Historian, Phlebotomy, and Processing Technician).
• Completion of all training through Lead Technician.
• Demonstrated understanding of quality assurance in an FDA-regulated environment.
• Effective communication, organizational, and technical/problem-solving skills.
• Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records.
• 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.
• Ability to multi-task and work as a team player.
• Innovation and coordination with all other center roles to effectively problem solve, ensure safety of staff and donors, and provide an exceptional customer experience.

Skills

• Technical/Functional (Line) Expertise.

Benefits

We offer a comprehensive benefits program, including:

• U.S. Hourly Wage Range: $19.00 - $27.17
• Short-term incentives
• Medical, dental, vision insurance
• 401(k) plan and company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits
• Sick time and vacation accrual

Pay

The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage 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.

Schedule

Production environment requiring the ability to walk and stand for the entire work shift. Requires frequent leaning, bending, stooping, crouching, and reaching above the shoulders and below the knee. Requires frequent lifting up to 26 lbs. and occasional lifting of materials 32 lbs. – 50 lbs. Must have fine motor coordination, depth perception, and ability to hear equipment sounds from a distance.