Quality Assurance Control

Jordan Weeks

**** ******* ***. ***** *****, California 91911 619-***-**** ********@*****.*** Objective

I am seeking a position within your company and your department where I can utilize and maximize my skills and quality assurance. To secure a position with a stable environment that will lead to a lasting relationship in the company or organization. I’d like to serve your company to the best of my ability. Experience

SR. Quality Associate Cellics Therapeutics October 2023-December 2023

(Contract)

• Perform receiving/inspection of materials and complete associated paperwork following Good Documentation Practices (GDP)

• Support Quality Manager with Document Control activities such as compiling paperwork for SOPs, updating SOP binders, issuing batch records

• Review documentation in support of routine Production operations (e.g.: line clearance and cleaning records)

• General Document Control tasks: issuance of notebooks and logbooks, maintaining of controlled document processing/formatting, photocopying, scanning, filing documents and preparing documents for archive.

• Review of equipment qualification, calibration, and protocols.

• Perform dynamic Environmental Monitoring in Cleanrooms for cGMP production runs.

• Compile data packets for stability runs.

• Support with equipment calibration record reviews.

• Other duties as assigned or identified

SR. Quality Assurance Analyst 3 D&K Engineering January 2023- August 2023

• Unit Issue Tracking (e.g., The Findings tally)

• Serial Number Tracking (Configuration Tracking & Management)

• Creation and continual involvement with Inspection Checklists & Travelers

• In-process Inspection

• End-of-Line Inspection

• Build Book (DHR for Medical Devices) Review for completeness.

• Program Work & Test Instruction initial review and potential editing

• NCR Initiation & Preliminary Investigative work

• Material Review Board (MRB) facilitator

• Deviation Oversight – Ensure no expirations, tied to unit build books (DHRs)

• CAPA System Facilitator

• Internal Audit participation

• Documentation Readiness Status Regularly Communicated to Program Stakeholders

• Performs other duties as assigned.

Quality Control Specialist Cue Health September 2020 – January 2023

• Perform quality control inspections on medical device components, assemblies, and chemicals.

• Conducts visual, dimensional, and functional inspection, as directed by quality assurance procedures and other.

• specifications

• Ensure measurement, test and inspection equipment is calibrated and in good condition.

• Generates non-conformance reports.

• Perform incoming receiving inspection, in-process, and final inspection of product, packaging and labeling.

• Ensure that product, at all stages of inspection, maintains proper identification, traceability, and inspection/test.

• Status Management of Product

• Fill out, organizes, reviews, maintains and archives quality control records.

• Perform other duties as required by the Quality Assurance Operations management.

• Closely follow all procedures and specifications and accurate in performing tasks

• Ensure full compliance with the corporate rules and regulations and perform associated and other duties as required.

Quality Assurance Specialist Pacira Pharmaceuticals October 2019 - September 2020

• Provide exceptional customer service to the company’s internal and external customers in all assigned tasks.

• Maintain programs and processes to ensure high quality products and compliance with current good manufacturing practices (GMP) Provide floor support for GMP activities.

• Monitor GMP Compliance of all in-process activities during GMP processing.

• Perform AQL particle inspection of in-process product vials prior to packaging.

• Gown qualified for entry into controlled manufacturing areas to perform quality functions as assigned.

• Perform real time review of executed Batch Documentation and prepare for eventual disposition by QA Management.

• Organize documentation for Bath history files and scans files.

• Ability to search, document, and generate quality event reports for Batch Release.

• Assist with any regulatory inspections and partner audits with Management oversight.

• Maintains databases as required.

Quality Control Specialist Sherpa Clinical May 2018 - September 2019

• Perform QC line clearance verification, in-process checks and monitoring of labeling and packaging activities on the floor.

• Perform QC inspection of incoming GMP materials according to appropriate material specifications.

• Assist product lot disposition by reviewing executed packaging records for completeness, accuracy, and compliance to GMP and company procedures.

• Assist document change control activities as needed.

• Support shipping operations, on as needed basis.

• Perform product lot disposition by reviewing executed packaging records for completeness, accuracy, and compliance to GMP and company procedures.

• Perform document change control activities as needed.

• Perform and lead in investigations, NCMRs and Complaints.

• Track and monitor CAPAs.

• Perform training as needed.

• Support Distribution activities.

• Collect Quality Metrics.

• Support the Quality Manager with internal, supplier, regulatory and customer audits.

• Perform QC line clearances, in-process checks and monitoring of labeling and packaging activities on the floor.

• Perform QC inspection or release of incoming GMP materials according to appropriate material specifications.

• Ensure department and company goals are met.

Associate Materials Management Ajinomoto Althea INC. May 2013-March 2018

• Responsible for the receipt of all GMP and non-GMP supplies, materials and equipment within Althea

• Follows Althea SOP’s for receiving, Raw Material Movement, Raw Material Specifications, Raw Material Inventory, Material Transfer, CSM Inventory, Final Product inventory, and Final Product Shipping, sampling and Dispensing of Raw Materials.

• Writes and Revises SOP’s as necessary to keep up with current GMP practices

• Trains junior associate personnel on GMP Receiving, Inventory Control, Sampling and Dispensing operations and GMP Shipping Practices.

• Interfaces with QAD ERP software modules daily.

• Trains staff on trouble shooting Receiving and Inventory electronic issues.

• Acts as the point person with the Accounting Department on receipts and invoice questions so that payments can be processed in an efficient manner and investigates issues as needed.

• Acts as the point person for ensuring the manufacturing allocated items are pulled and issued to specific projects and investigates issues as needed.

• Responsible for re-counts of Raw Materials and Final Product if an item is to be found to be out of tolerance.

• Schedules and obtains shipping quotes for all product shipments.

• Responsible for leading client tours and audits.

• Acts as a point person for initiating deviations and works with Materials Management Supervisor to come up with efficient solutions.

• Maintains company truck records and trains junior employees on the use of the company truck.

• Operated company vehicles to transport materials between multiple locations within Althea.

• Trains Materials Management junior employees on sampling and dispensing hazardous materials in accordance with GMP regulations.

• Trains junior employees on forklift safety procedures and ensuring forklift checklists are being maintained.

• Responsible for being on-call when required to support operations.

• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

• Responsible for office orders.

• Responsible for searching for competitive prices on equipment and units as well as purchasing.

• Point person for all outside vendors of equipment.

• Quality Control Checks on all incoming Raw Materials.

• Performed visual inspection as well as any identification testing as needed.

• Collected and researched for any certificates of analysis if none were provided.

• Sample identification testing for any incoming Raw Materials. Education

GENERAL EDUCATION SEPTEMBER 2000- JUNE 2004 CASTLE PARK HIGH SCHOOL, CHULA VISTA, CALIFORNIA

Skills & Abilities

• Oversees different teams and projects.

• Team leader as well as team player

• Lead contact when management was

not available.

• Quick learner

• Self-motivated

• Word/Excel/Outlook/Internet

• AQL Testing

• Sample Submission

Contact this candidate