Jaivion Curtis
Raleigh,NC
Overview
4
4
years of professional experience
Work History
Senior Inprocess Quality Engineer
Guerbet
03.2024 - Current
- Compliance Monitoring: Ensured all production and packaging operations met or exceeded site SOPs and cGMP standards through consistent monitoring and timely review of GMP documentation at critical process points.
- QA Inspections: Conducted thorough QA inspections, including sample defect detection, to ensure product compliance with company requirements.
- Exception Handling: Acted as the primary QA event response personnel, performing initial impact assessments, product containment, and immediate corrective actions in response to exceptions in the production/packaging areas.
- Audit Participation: Supported internal audits and investigations into quality events, contributing to corrective action planning and process improvements.
- Operational Support: Provided daily support to the operations and packaging areas, including tasks such as line clearance verification, material segregation, and documentation review in real-time.
- Process Improvement: Participated in facility meetings regarding preventive maintenance and calibration, supporting area shutdown or maintenance projects, and conducting pre/post activity inspections.
- Team Development: Assisted in identifying team training needs and developing professional skills among team members.
MQA Specialist
Indivior
02.2023 - 03.2024
- Provided quality oversight for all critical manufacturing processes
- Works closely with Quality Management
- Clearly communicates complex issues to Management personnel
- Evaluated the manufacturing areas for recommended improvements that would eliminate the potential for deviations
- Close interaction with Production personnel to complete in-process batch record review, resolve batch related issues, and complete timely final batch record approvals in order to meet release scheduling
- Gown qualified for Aseptic processing area
- Identified deviations and ensured the deviations were initiated by the appropriate personnel
- Initiated Action Plans requirements as needed to address investigations or compliance related activities
- Perform in analysis of inspection rejects; assisted in investigation of causes and implementation of corrective actions
- Performed AQL checks on products
- Provided good aseptic technique and gown re-training to individuals
- Ensured all processes and products are in compliance with all local, state, and federal rules and regulations
- Oversaw that processes are in CGMP compliance
- Established systems that identifies opportunities for improvement.
Quality Lab Technician
BURT BEES
03.2022 - 02.2023
- Assisted with microbial testing of finished goods, bulk, and raw materials
- Accurately documented testing information and results in DTR
- Perform bulk testing as a backup
- Prepared and sterilized test media
- Reviewed all DTRs for release of materials
- Created accurate COAs in Content for finished goods testing
- Distribute finished good samples for testing
- Review COC (Chain of Custody) and Line Clearance forms for finished goods samples
- Performed non-micro finished goods testing: Specific gravity & pH-2
- Operated micro lab equipment: Neogen Soleris, Autoclave-2
- Operated pH meter, viscometer, penetrometer, TOC analyzer-2
- Ability to calibrate pH meter and scales
- Assist in all micro suite cleaning processes.
Compounding line lead
BURT BEES
04.2021 - 03.2022
- Dual position with PROCESS OPERATOR
- Maintained a safe working environment for employees and adhered to all safety regulations
- Immediately address any safety concerns or issues
- Ensured all products meet appropriate quality standards through the Content system at start up and throughout shift
- Track and analyze results and manage rework and scrap
- Staffed personnel appropriately on the line and manage break and lunch times with accordance to line downtime and schedule
- Responsible for centerline checklist and CIL adherence during shift
- Audited event tracking system in LEDs system to ensure adherence
- Track and analyze losses for their lines
- Completed projects as assigned by the Business Unit Leader and/or Shift Lead
- Created detailed work instructions, job aids, and OPL for assigned production-related tasks
- Executed production priorities and plans, track performance of assigned unit against goals, and work with Business Unit Leader to continuously improve line performance
- Assisted in execution of training with the Training and Qualification pillar to enable operator and line flexibility.
Process Operator
BURT BEES
04.2021 - 03.2022
- Dual position with COMPOUNDING LINE LEAD
- Put together of pumps, mills, hoses, fittings, homogenizers, mixers and other Compounding equipment used for processing
- Interacted with Pre-Weigh, Quality, Materials Management, Production, and Leadership daily
- Performed verification and visual checks on all raw materials to make sure material numbers, lot numbers, quantities, and expiration dates are correct
- Provided training on batching processes/procedures to current/new employees
- Adhered to all current Good Manufacturing Practice (cGMP) guidelines, especially with regards to maintaining a clean/safe work environment
- Safety and health regulations by maintaining raw material storage locations in a neat and orderly condition
- Worked directly with Processing Engineers and R&D to continuously improve BMP's, system processes, and assist in the formulation of products
- Troubleshooting mixing/processing issues and provide analysis to Processing Engineers and R&D regarding batch issues/problems
- Formulated pilot plant batches with the assistance of Process Engineering
- Perform the setup/startup of all batching vessels and check all controls for adherence to Batch Manufacturing Procedures (BMP's) procedures
- Ensured all BMP steps are adhered to under Quality guidelines and cGMP regulations and sign off once verified
- Held accountable for all safety and SOP training on shift
- Maintained excellent team-oriented working relationship among team members
- Leaded Continuous Improvement Teams and facilitate meetings as necessary to improve department.
Pre-weigh associate
Burt Bees
01.2021 - 04.2021
- Practiced current Good Manufacturing Practice (cGMP) guidelines, especially with regards to maintaining a clean/safe work environment
- Accurately weighed raw materials per Batch Manufacturing Procedure (BMP) formula sheet
- Logged accurate records of raw materials being consumed in Pre-Weigh Department, as well as recording these issuances on Pre-Weigh Sheets
- Reported all inventory inconsistencies and discrepancies to the Compounding Shift Lead
- Located all transferred raw materials in dedicated pre-weigh locations and manage the replenishment of materials to these locations
- Cycle counted and maintain accurate inventory records within the Compounding Department.
Education
Associate in Science (AS) -
Wake Technical Community College
Raleigh, NC08.2021
Skills
- CGMP
- Aseptic Technique
- Quality Assurance
- Laboratory Experience
- Quality Management
- Control Plan Development
- Quality processes
- Root Cause Analysis
- Quality improvement plans
Timeline
Senior Inprocess Quality Engineer
Guerbet
03.2024 - Current
MQA Specialist
Indivior
02.2023 - 03.2024
Quality Lab Technician
BURT BEES
03.2022 - 02.2023
Compounding line lead
BURT BEES
04.2021 - 03.2022
Process Operator
BURT BEES
04.2021 - 03.2022
Pre-weigh associate
Burt Bees
01.2021 - 04.2021
Associate in Science (AS) -
Wake Technical Community College
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