Quality Lead Technician

About the role

Monitors designated systems and activities, ensuring 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. Performs duties associated with Quality, including reviewing operational records, tracking deviations, conducting audits, and maintaining staff qualifications.

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.
• 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.
• 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.

Requirements

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.

Qualifications

High School Diploma or equivalent required. Associate or Bachelor’s degree preferred.

Skills

Effective communication, organizational, and technical/problem-solving skills. Ability to read and follow Standard Operating Procedures (SOPs) and maintain complete and accurate records. Fine motor coordination, depth perception, and ability to hear equipment sounds from a distance. Pro-longed glove wear due to potential exposure to blood borne pathogens (risk level 1).

Benefits

Comprehensive benefits program, including 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.

Pay

$20.00 - $28.60 per hour

Schedule

Full time