Quality Lead

Regulatory Toolkit; Gainesville (FL); On-site; USD 26,000 - 37,000; Full time

Job summary

BioLife Plasma Services in Gainesville, FL is seeking a Lead Technician to monitor plasma center operations and support the quality system within a cGMP environment. The role requires training staff, overseeing donor processing, and ensuring SOP compliance while coordinating with management and external auditors.

The ideal candidate will hold a high school diploma (or equivalent) with certification in Medical History, Phlebotomy, and Processing Technician areas, plus relevant experience.

Qualifications

• Essential: High School Diploma or equivalent required.
• Desired: Associate or Bachelor’s degree preferred.
• Certification in Medical History, Phlebotomy, and Processing Technician operations.

Responsibilities

• Reviews records to ensure completeness and cGMP compliance.
• Tracks deviations and reports to center management and QMR.
• Conducts monthly QA audits for donor, processing, and training areas.
• Ensures SOPs are current and followed through observation.
• Lead Technician duties and staff training in donor center procedures.

Skills

Quality assurance

Documentation

Training staff

Communication

Problem solving

Education

High School Diploma or equivalent

Associate or Bachelor’s degree

Tools

Medical History Certification

Phlebotomy Certification

Processing Technician Certification

Job description

Job Description

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 designated systems and activities, according to tasks trained and assigned, 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. Is able to perform all technical tasks required within the work areas and will work in these areas as a Lead Technician (or Center Supervisor by exception) when not acting as the Quality Lead Technician.

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

• Performs duties associated with Quality (including but not limited to): (50%)
• 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.
• In the absence of a QMR, works in collaboration with the management team to prepare for and host (if needed) internal auditors and external inspectors. Assists 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. (30%)
• Provide leadership and training assistance in support of center management and supervisory team, including oversight of operational flow. (10%)
• Maintain certification and perform all required duties of Lead Technician. (10%)

Dimensions and Aspects

• Technical/Functional (Line) Expertise
• 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.
• 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).
• Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment.
• 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

• Refers to Center Manager for guidance on complex, medium-impact or above decisions (internal)
• Refers to management team for escalated donor/employee concerns (internal)

Interaction

• Responsible for providing exceptional customer service to donors (external) and fellow employees (internal)
• Attend staff meetings and other team meetings as required.
• Good verbal communication and customer service skills.
• Ability to multi-task and work as a team player.

Innovation

Coordinates will all other center roles to effectively problem solve, ensure safety of staff and donors, and provide an exceptional customer experience.

Complexity

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.

Due to potential exposure to blood borne pathogens (risk level 1), 90% of work tasks require pro-longed glove wear

Education, Behavioral Competencies and Skills

• Essential: High School Diploma or equivalent required
• Desired: Associate or Bachelor’s degree preferred

Additional Information

• FLSA Classification (US) - Non-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 - FL - Gainesville

U.S. Hourly Wage Range

$19.00 - $27.17

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.The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.

For information about our benefits, please click here.

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.

Locations

USA - FL - Gainesville

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

No