CARMEN CARCANO

818-***-****

acd9cv@r.postjobfree.com

PROVEN PROFESSIONAL WITH 10+ YEARS EXPERIENCE IN QC/QA

•

• • Reviewed and edited work instructions

Tested Raw Materials and Products

• and SOPs. Initiated ECO/DCO for

Prepared solutions and powder mixes

• updates

Experience in product development

• Conducted process oversight and internal

(R&D)

• audits

Validated processes for accuracy and

• Worked with scientist, engineers,

compliance to requirements

• supervisors and customers on special

Compliance to cGMP, GLP, HACCP,

testing requests

and Safety

•

• Maintained test and batch records. Issued

Update QA database on in/out bound

Certificate of Analysis

inspected material. Tracked raw

• Participated on problem solving and

material inventory daily.

• continual improvement teams

Tracked/Reported Quality Performance

for compliance to the Quality System

PROFESSIONAL EXPERIENCE:

Quallion LLC, Sylmar, CA 2013 - 2014

QC Inspector 3/Mission Assurance

• Executed Mission Assurance protocol in support of Lithium Ion Cell Manufacturing for

Aerospace and Implantable/Non-Implantable medical applications, including in-process

quality checks

• Ensured operational execution are in compliant to ISO13485 and AS9100C

• Oversaw operational process work flow and verified accuracy using operation and assembly

procedures. Recorded and reported any deviation from prescribed process to the Quality

Manager and Director for corrective action

• Maintained inspection results as part of the corrective action and record retention process

• Participated in action teams per Quality Director continual improvement process

Bio-Nutraceutical, Inc, Chatsworth, CA 2001 – 2013

Multiple Roles in QC/QA, Production, R&D

QA/QC

• Reviewed manufacturing documents, processing steps and laboratory test records

• Inspected and reviewed documentation of components, labels and finish good for

proper disposition

• Tested raw materials against specifications

• Examined product specification and how they related to product manufacturing,

calculated product yields and reconciled deviation. Released products if all documents match

written specifications

• Prepared solutions for production runs

• Communicated problems to production supervisor and manager, resubmitted

documentation for corrective action where required

• Maintained test and reconcile batch records. Issued Certificate of Analysis

• Reported findings to QA/QC Supervisor or managers. Made recommendations for

corrective action, prepared notices for non-conforming products, components and labels

• Performed in house audits for compliance to Quality Systems, investigate and reported

on customer complaints

• Supported National Sanitation Foundation (NSF) external audits

• Inspected and approved product components and labeling to written specifications.

Reviewed work stations for manufacturing readiness.

• Monitored product and equipment for correctness and cleanliness throughout the

production cycle.

• Selected samples for in-process, final evaluation, and performed appropriate tests.

• Audited manufacturing area for compliance to cGMP, HACCP, and Safety

requirements.

• Update QA database on in/out bound inspected material. Tracked and reconciled raw

material inventory daily.

• Monitored and pulled out sample products during manufacture of verification lots.

• Documented/Data Entry inspection results into database. Initiated Engineering

Change Request/Order (ECR/ECO) and Document Change Requests/Order (DCR/ECO).

• Production and R&D

• Entered appropriate calculations from R&D formulation and procedure.

• Assigned codes for formulas and codes for customer supplied materials (RM)

• Activated formulas and maintained all master files with RM information, customer approval,

nutritional supplements information

• Created Supplements Facts labels and Certificate of Analysis for finished products.

• Reviewed in-coming labels against master files. Maintained database files updated related to

customer specifications on a continuous basis.

• Reviewed certificate of analysis, product name, heavy metals, microbiological test, physical

characteristics, and expiration date. Checked certificate of analysis with company

specifications.

• Planned, directed and coordinated activities relating to engineering and maintenance

operations of utilities and equipment used in production

Training

• •

ASQ Quality Manager/OE Classes Allergen Training (Raw Material)

• •

Leadership Skills Sanitation Protocols

Education

•

• 2008 General Education at Los Angeles Mission College

• 1985 San Fernando High School

Contact this candidate