Maria A Villeda
Brentwood,NY
Overview
23
23
years of professional experience
Work History
Quality assurance supervisor
LNK INC. International
Hauppauge, USA
01.2007 - Current
- Oversee over 12 Quality Assurance Inspectors personnel in several departments including packaging, warehouse and raw materials.
- Oversee all activities related to packaging department including reviewing of documentation prior to batch recorder release to ensure it’s completed within the FDA and cGMP regulation.
- Assisting in staffing of Quality Assurance, developing and maintaining QA’s personnel training and safety programs, and ensure company policies are followed.
- Assisting and leading in resolving compliance and Non-compliance, deviation and investigation.
- Oversee creation maintenance of temperature monitoring program (Vaisala) including record keeping of logs and weekly review and approval.
- Oversee the calibration program including but not limited to Calibrated thickness gauges.
- Monitor and improve date integrity.
- Ensure company SOP’s are adequate and meet cGMP Standards.
- Assist in internal audits and responsible for findings, follow up, corrective actions and planed reports.
- Planning schedule coverage and overtime.
- Executing protocols (cleaning verification, cleaning validations, campaigns).
- Ensure that all major repairs, PM’s, change control are reviewed and approved in a timely matter.
- Approved of QA’s PTO and write ups.
- Perform AQL on drug product as per SOP’s and ensure is within validated limits.
Quality lead
LNK INC. International
Hauppauge, USA
01.2007 - Current
- My job was to make sure all QA’s were following proper procedures and doing their checks on time, make sure that all the areas were covered.
- Responsible for reviewing and closing paperwork.
- In charge of cleaning validations and collecting samples for the lab.
- Manage personnel in packaging, warehouse and promo departments making sure all QA’s are following Good Manufacturing Practices and SOP’s.
- Prepare samples for bulk extension for lab.
- Calibrate packaging scales daily.
QA specialist in blistering
LNK INC. International
Hauppauge, USA
01.2007 - Current
- Quality assurance on blistering responsible for machines being cleaned as per SOP.
- Verify components such as foil, PVC, bulk product and stamp.
- When I release the work order we collect samples of blisters and check for forming, lot number and expiration date, legibility of print information, sealing, and quality of the blister.
- Performed leak test every hour for seal integrity testing and also performed visual inspections.
Quality assurance in solid dosage
LNK INC. International
Hauppauge, USA
01.2007 - Current
- In charge of 4 packaging lines. My job is to verify line clearance and if acceptable; provide start –up approval.
- Review work orders verifying for components bottles, caps, over seal (if applicable) bulk quantity, sleeves, cotton, and desiccant and follow up with any special instructions required by the costumer.
- At the time of release verify the bottle counts by utilizing counting scale, quality of the product, lot number expiration, labeling, tamper evident, foil overall appearance, crooked and wrinkled labels.
- Perform quality inspections every hour and ensure the acceptance criteria were met and recorder.
General cleaner
zebra technologies
Holtsville, USA
01.2007 - 01.2008
- In charge to keep the facility clean.
- Clean offices by vacuum, removing trash, separate recycling.
- Broom and mop a big lobby and hallway, clean the windows and desks.
- Clean bathrooms and re stocking supplies.
- Responsible for cleaning breakroom.
Quality assurance
PDK Labs
Hauppauge, USA
01.2005 - 01.2006
- In charge of manufacturing area had a total of 4 machines.
- Review the work order and to learn the details of the work order and make sure the machine was cleaned prior to QA inspection.
- Checked that temperature and humidity in the room were within limits before a job can be started.
- Check for the tablets, compression, imprint, thickness, hardness and friability were being done and ran within specifications.
- In charge of scanning bulk orders and finished product for the costumers.
Quality control
OGM Cosmetics Laboratories
Hauppauge, USA
01.2004 - 01.2005
- In charge of cosmetics procedures.
- Use to do lab testing temperature control, checked for color, flavor for every cosmetic sample received from the blender area.
Timeline
Quality assurance supervisor
LNK INC. International
01.2007 - Current
Quality lead
LNK INC. International
01.2007 - Current
QA specialist in blistering
LNK INC. International
01.2007 - Current
Quality assurance in solid dosage
LNK INC. International
01.2007 - Current
General cleaner
zebra technologies
01.2007 - 01.2008
Quality assurance
PDK Labs
01.2005 - 01.2006
Quality control
OGM Cosmetics Laboratories
01.2004 - 01.2005