Administrator, Quality Assurance

LeMaitre Vascular; Burlington, Northern (MA, KY); Hybride; USD 33 000 - 47 000; Plein temps

Résumé du poste

LeMaitre Vascular in Burlington, MA is looking for a detail-oriented QA/QC professional with experience auditing documentation across recovery, processing, cryopreservation, labeling, storage and distribution of tissue products.

The role emphasizes ensuring compliance with FDA 21 CFR Part 1271 and AATB standards, performing chart audits, data entry, and document control, while using MS Office and communicating in English.

Qualifications

• High School Diploma or GED required.
• 1-2 years of related experience.
• Posses the ability to learn on the job and develop critical thinking skills.
• Microsoft Office

Responsabilités

• Responsible for quality review of documents generated during recovery, processing, cryopreservation, labeling, storage, and distribution of tissue.
• Responsible for making sure company is compliant with adhering to Good Tissue Practices established by FDA 21 CFR Part 1271, AATB and company procedures and policies.
• Auditing charts –Auditing Batch Records and Data Entry.
• Auditing labels and uploading documents into Vitals database.
• Audit RFA culture reports and file donor charts.
• Adheres to company policies, procedures, and documentation requirements.
• Treats others with courtesy, sensitivity, and respect at all times.
• Other duties as assigned.

Connaissances

Fluent in English

Formation

High School Diploma or GED

Outils

Microsoft Office

Description du poste

Overview

Detail oriented quality person with experience in QA/QC or auditing of documentation. Responsibilities include quality review of documents generated during recovery, processing, cryopreservation, labeling, storage, and distribution of human allografts. Experience with excel, word, and outlook required.

Responsibilities

• Responsible for quality review of documents generated during recovery, processing, cryopreservation, labeling, storage, and distribution of tissue.
• Responsible for making sure company is compliant with adhering to Good Tissue Practices established by FDA 21 CFR Part 1271, AATB and company procedures and policies.
• Auditing charts –Auditing Batch Records and Data Entry.
• Auditing labels and uploading documents into Vitals database.
• Audit RFA culture reports and file donor charts.
• Adheres to company policies, procedures, and documentation requirements.
• Treats others with courtesy, sensitivity, and respect at all times.
• Other duties as assigned.

Pay range $24.00-$34.00 per hour plus bonus.

The range provided is based on what we believe is a reasonable estimate for the base pay range for this job at the time of posting. The actual base salary pay will be based on a number of factors such as education, qualifications, certifications, experience, and other job-related factors permitted by law.

Qualifications

High School Diploma or GED required

1-2 years of related experience.

Posses the ability to learn on the job and develop critical thinking skills.

Microsoft Office

Fluent in English.

EEO Statement

In order to provide equal employment and advancement opportunities to all individuals, employment decisions at LeMaitre Vascular will be based on merit, qualifications, and abilities. LeMaitre Vascular does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, breastfeeding or related medical conditions, religious dress, military or veteran status or any other characteristic protected by law.

This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination, and access to benefits and training.

Applicants with disabilities may contact LeMaitre HR coordinators via telephone, fax, e-mail, and other means to request and arrange for accommodations. If you need assistance to accommodate a disability, you may request an accommodation at any time. Please contact LeMaitre HR at [e-mail].