Quality Lead Technician jobs in United States
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BioLife Plasma Services ยท 1 day ago

Quality Lead Technician

BioLife Plasma Services is dedicated to improving the lives of patients with rare diseases. They are seeking a Quality Lead Technician to monitor systems and activities ensuring compliance with Good Manufacturing Practices while providing leadership and training support to staff.

Health CareMedicalPharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

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

Qualification

CGMP complianceQuality assurance auditsCertification in operational areasTechnical problem-solvingEffective communicationFairnessHonestyPerseveranceCustomer serviceLeadershipIntegrityTeam player

Required

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
High School Diploma or equivalent required

Preferred

Associate or Bachelor's degree preferred

Benefits

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
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation

Company

BioLife Plasma Services

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Biolife Plasma Services is a healthcare Pharmaceutical firm that offers life-saving therapeutics that benefit thousands of people every day.

H1B Sponsorship

BioLife Plasma Services has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2023 (2)
2022 (2)

Funding

Current Stage
Late Stage

Leadership Team

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Ashley Slaets
Training and Development Partner
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Cait Reynolds
Human Resources Business Partner
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Company data provided by crunchbase