Katrena Hodges
North Plainfield,NJ
Summary
To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
Overview
9
9
years of professional experience
Work History
Diagnostic Tech Specialist
Roche Molecular Systems
07.2019 - 07.2023
- Skilled in the set-up and operation of automatic and semi-automatic filling, labeling, and Packaging/warehouse equipment to provide coverage as required to meet production plans
- Supervised sub-teams of assigned operators to perform filling/packaging/ labeling/label printing and/or visual inspections to complete assigned production operations
- Set-up, troubleshoot, and participate in changeovers of Fill/Package/Label equipment as required
- Assisted in the training of Diagnostic Tech and Diagnostic Inspectors for Filling, Packaging operations to perform all production tasks to meet replenishment demands
- Filled in a Diagnostic Technician Lead when needed
- Ensured all documentation generated during scheduled manufacturing operations (batch production records, packaging records, in-process test data) is completed correctly and accurately by the subteam
- Performed SAP system transactions as required to ensure all components meet requirements pertaining to lot numbers, expiration dates, intermediates, reconciliation, etc
- In SAP, performs transactions to issue components to order, receive stock into inventory and issue samples as required
- Understands GMP, QSR, ISO and RMS Quality regulations and ensures operations are performed according to those requirements
- Operated MES Pharmasuite for packaging operations which included completion of electronic batch records in occordance to SOPs and cGMPs.
Diagnostic Technician
Roche Molecular Systems
07.2019 - 06.2021
- Participated in the operation of filling, labeling & packaging equipment of varying complexity and in accordance with Production Manufacturing Records, applicable SOPs, and ISO and cGMPs requirements to produce finished intermediates and final kits
- For Filling Operations, performed aseptic gowning and performing all filling tasks in the aseptic environment
- As part of the production team, performed in-process quality checks for specific quality attributes (Fill Check, Torque check, Vision System Check, Label Alignment Check etc.)
- Inspected products for defects and conformance to quality standards and applicable SOPs as well as applicable ISO and cGMP requirements
- Assisted in completing all necessary production documentation (Production Manufacturing Records) and associated SAP transactions to ensure that all components meet requirements pertaining to lot numbers, expiration dates, intermediates, reconciliation’s, etc
- Cleaned work area and decontaminates work surfaces in accordance with defined procedures, and performs duties in accordance with SOPs, QSRs, and all safety regulatory requirements
- As required performed scheduled environmental monitoring activities in the Filling Suites
- As required, performed warehousing activities according to defined procedures, which may include picking, issuing, returns, internal distribution of goods, receiving, shipping, etc
- Other duties as assigned by management.
Production Technician
Impax Labs
03.2016 - 11.2017
- Followed SOPs and cGMP requirements
- Operated line equipment for filling, labeling & packaging of product
- Cleaned operating equipment and document as required.
Aseptic Operator
DPT Labs
05.2014 - 08.2015
- Operated line equipment for filling, labeling & packaging of product
- Worked in sterile clean room environment
- Followed SOPs and cGMP requirement
- Checked documentation and proper expiration dates
- Electronic batch record execution
- Quality Control & Assurance
- CGMP
- Sterile environment procedures
- Recognized by supervisors and co-workers for attention to detail and effective communication
- Performed excellent and quality production.
Education
Associate of Science - Computer Information Systems
Penn Foster College
Scottsdale, AZ12.2024
Skills
- Time Management
- Corrective Actions
- Judgment and Decision-Making
- Critical Thinking
- Production Work
- Inspection Protocols
- Quality Control
Timeline
Diagnostic Tech Specialist
Roche Molecular Systems
07.2019 - 07.2023
Diagnostic Technician
Roche Molecular Systems
07.2019 - 06.2021
Production Technician
Impax Labs
03.2016 - 11.2017
Aseptic Operator
DPT Labs
05.2014 - 08.2015
Associate of Science - Computer Information Systems
Penn Foster College
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