Quality Manager - Houston, United States - Gene by Gene

Description

Job Description


Job Description Description:

Job Summary:
The Quality Manager has the responsibility of ensuring adherence to and
improvement of the Laboratory Quality Plan and of ensuring that compliance with all
accrediting bodies is maintained.


Primary Responsibilities:

• Confirms with office and laboratory management that the laboratory quality plan is

adhered to

• Updates the quality plan as necessary and informs management and affected staff of

any changes

• Works with laboratory leadership to update and conduct regular reviews of SOP's and

confirm they are appropriate for maintaining accreditation

• Maintains awareness of all requirements issued by accrediting bodies, including any

changes or updates

• Works to acquire and maintain accreditations and certifications, including preparation

for and coordination of any required inspections

• Ensures all standards and requirements for accreditations are met, including but not

limited to:
o Personnel competencies and reviews are documented and up to date
o Laboratory instrumentation maintenance and services are performed and
documented in a timely fashion
o Internal and external proficiency tests are completed and submitted on schedule
o Documentation and follow-up are completed for any corrective action /
preventative action incidents
o Documentation is completed and maintained for any validations of new
processes and/or technology conducted by the Clinical Research team
o Validation checklists are completed and submitted to the appropriate regulatory
bodies per requirements for any new laboratory developed test

• Administers the MediaLab Account (online quality management software)

o Ensures all documents are up to date, including personnel documents, SOP's
(current and retired), Continuing Education, and compliance documents for all
laboratory users
o Performs InspectionProof and MediaLab backups once a month
o Conducts regular reviews and inspections of SOP compliance in the laboratory to
ensure that personnel are adhering to approved SOP's
o Completes account creation and onboarding for new employees within
MediaLab

Requirements:

Required Qualifications:

• Bachelor's degree or higher in a Biological or Chemical Science or related field (Master's

degree or above preferred)

• At least 5 years of experience working within Laboratory Quality Management Systems
• Previous laboratory experience, including experience conducting instrument

maintenance, QA/QC compliance, and following laboratory protocols

• Experience with maintaining documentation, preparing for, and conducting quality

inspections

• Experience completing validations of new laboratory assays and procedures
• An understanding of regulatory requirements and quality control standards
• Meticulous attention to detail
• Ability to communicate effectively and accurately, both verbally and in writing
• Ability to function independently with minimal supervision

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