Quality Supervisor
Company: Biostem Technologies
Location: Pompano Beach
Posted on: March 11, 2023
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Job Description:
Job Title: Quality SupervisorScope of Function:The Quality
Supervisor will oversee and have responsibility for QA document
control including issuing process records, label creation,
maintaining the training database as well as QA final disposition
pertaining to final HCT/P shipment. Works closely with
manufacturing operations, facilities, business operations and
quality personnel. Supervise QA staff. Reports to: Director of
QualitySpecific Duties: Supervise QA personnel as well as execute
the tasks of the BioStem QMS regulated document and training system
as per SOP. Create WIP, final package and final patient labels for
manufacturing purposes. Maintain the training matrix/database as
well as individual files/Binders. Sort, scan, file regulated
documents including process records, protocols, and SOP's/Policies.
Perform SOP and Policy creation, revision and reviews. Owner of the
annual document review process. Perform final disposition of HCT/Ps
providing QA oversight. Review and approve documentation used in
raw material and component release program. Oversee the medical
chart program providing guidance and back up.Participate in
internal and external audits as well as the Change Control program.
Provide guidance with the supplier qualification program. Overall
provisioning and maintenance of the Master Control electronic
quality systems. Maintain Quality Management System dashboard and
performance metrics.Education and Experience Required:-- AA degree
or BA desired-- Three to Five year's experience in a Biotech
manufacturing environment or related industry focused on quality
operations with requirements within a related QMS regulated
environment.-- Experience with AATB guidance's and/or FDA 21CFR1271
and or CFR211 regulations, usage of CAPA system.-- High proficiency
in Microsoft Office, including Word, Power Point and Excel--
Detailed experience in a QMS system.Other Skills and Abilities:--
Possess attention to detail, with the ability to supervise others--
Self-motivated individual who can work in a multi-personnel team.--
Good troubleshooting, communications, teamwork as well as team
leading skills.-- Able to lift 35 poundsQualifications:-- Must
possess solid teamwork skills to interface with Medical Director,
Manufacturing, suppliers, and recovery agencies ensure smooth
production and site operations.-- Supervise QA personnel and report
issues to immediate supervisor (Director of Quality).-- Proficient
in Microsoft Office applications-- Proficient working in a QMS
systemSafety/PPE Policy:Adhere to company safety and PPE
policies.Participate in the Safety Program for the site as QA has
oversight of all Environmental Health and SafetyPI207644381
Keywords: Biostem Technologies, Pompano Beach , Quality Supervisor, Other , Pompano Beach, Florida
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