Quality Supervisor

Company: Biostem Technologies
Location: Pompano Beach
Posted on: March 11, 2023

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