Mary Nasovann
Summary
Perceptive Quality Assurance professional with 19 years of experience reviewing and optimizing systems and processes. Observes and collaborates with main workforce to understand and streamline standard operating procedures. Innovative in increasing productivity and eliminating waste. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. Dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities utilizing interpersonal skills, excellent time management and problem-solving skills to help achieve company daily and long-term goals.
Overview
19
19
years of professional experience
Work History
Quality Assurance Coordinator
International Vitamin Corporation
12.2017 - 01.2023
- Initiate change requests (CCR) for Master Batch Records to revise and implement changes
- Delegate, maintain and follow up on client's change orders and deviations for product specifications and raw materials
- Assist the client/customer with their inquiries and document requests
- Generate Certificate of Origin for product exporting outside of the U.S
- And obtain other export documents and certificates
- Maintain and compile updated documents and certificates for Kosher, Organic, Sports and Content
- Certified products
- Create Finished Product Specification Sheets for new and existing products
- Create Certificate of Ingredients for new and existing products
- Create Certificate of Analysis for new and existing products
- Maintain various certificates, registrations and licenses applicable to the facility
- Maintain the Stability Study Program
- Compile and review compliance documentation associated with the raw material approval program
- Approve Master Batch Records and Quality Control Reports
- Assist the Quality Management Team in preparing for 3rd party, state and government agency inspection audits
- Assist the Quality Control Manager and VP of QA/QC/RA with various projects
- Assist Quality Assurance Manager on SOP trainings.
Quality Assurance Documentation Associate III
Par Pharmaceutical
08.2008 - 12.2017
- Review and approve executed manufacturing batch records
- Review and approve C of A in StarLims
- Review and approve SQAR for raw materials
- Review and approve Stability SQAR for finished products
- Assign expiration date and bulk hold time for finished products
- Assign expiration date and retest date for raw materials and packaging components
- Make status transactions (release, reject, hold, etc.) in JDE for finished products and raw materials
- Request, issue, review and approve reject labels
- Open deviations in Trackwise to initiate investigations
- Enter data and errors in RFT database for reviewed executed manufacturing batch records
- Train new and existing employee(s) as needed
- Assist QA Clerk with issuing and receiving manufacturing batch records as needed
- Assist QA Clerk with issuing protocol for execution as needed.
Pharmacy Technician
UnitedHealth Group
01.2008 - 08.2008
- Process mail order prescriptions
- Verify prescription orders and inventory
- Identify method of payments and copays
- Verify insurance and process claims
- Make outbound calls/faxes with inquires to both patients and doctor's offices
- Escalate drug related calls to pharmacists when appropriate
- Resolve prescriptions with hold orders and payment issues
- Assist patients regarding non-discretionary information, benefits, use of plan, copays, status of orders,claims and questions.
Administrative Assistant
Nucare Pharmaceuticals, Inc
03.2007 - 01.2008
- Create purchase orders for raw materials and packaging components
- Create and process Goods Receipts in SAP/Sage for raw materials received
- Enter invoices from various pharmaceutical vendors
- Enter credits and returns from various pharmaceutical vendors
- Order Scheduled II drugs and fill out appropriate forms (222 form)
- Call various pharmaceutical vendors for orders, pricing, credits on shortages and discrepancies
- Create bulk and product numbers in SAP/Sage
- Assist Operation Manager as needed.
Customer Service Representative
Nucare Pharmaceuticals, Inc
01.2006 - 03.2007
- Process phoned, faxed, and emailed medication orders from customers
- Process Goods Receipts for raw materials in SAP/Sage received
- Enter invoices from various pharmaceutical vendors
- Enter credits and returns from various pharmaceutical vendors
- Assist customers with pending orders, shipped orders, pricing or quotes on pharmaceuticals and pharmaceuticals availability
- Create bulk and product numbers in SAP/Sage
- Archive and/or retrieve processed customer's medication orders
Quality Control Supervisor
Nucare Pharmaceuticals, Inc
09.2003 - 05.2005
- Supervise employees within the department
- Train employees on new and revised SOPs
- Issue Non-conformance reports for unacceptable products
- Review and approve executed packaging batch records
- Issue packaging batch records for execution
- Assure all drug products and other components are correct, are to prescribe quality standards and meet specifications
- Inspect and document customer returns
- Sample and inspect controlled substance (Scheduled Drugs)
- Handle controlled substance to and from the controlled cage
- Handle pharmaceutical retain samples
- Comply and enforce operations according to company's SOP and cGMP
Education
License in Pharmacy Technician -
American Career College
Anaheim, CAHigh School Diploma - Medical
David Starr Jordan
Long Beach, CASkills
- Microsoft Office, Adobe, JD Edwards, Reports Now, Trackwise, ComplianceWire, MasterControl, StarLims, Oracle and Ensure
- Operation
- Organization
- Scheduling
- Planning
- Coordinating
- Quality Assurance
- cGMP
- Quality Control
- Customer Service
- Manufacturing
- Document Management
- QA/QC
- Pharmacy Technician Experience
- FDA regulations
- Submissions of certifying products and registrations
- ANSI/ASQ
- Change Control
- Document Control
- Process Validation
- New Product Validation
- Stability Study (Protocol, SER, Stability SQAR)
- Master Manufacturing Batch Record
- Packaging Batch Record, Component, Label, and Insert/Outsert
- Projects
- Audits
- Problem solving
- Communication
- Detail oriented
- Time management
Accomplishments
- EHS Program (07/2012-08/2013)
- JD Edwards Validation Project (09/2013)
- Certified Trainer (SME) (02/2017)
Timeline
Quality Assurance Coordinator
International Vitamin Corporation
12.2017 - 01.2023
Quality Assurance Documentation Associate III
Par Pharmaceutical
08.2008 - 12.2017
Pharmacy Technician
UnitedHealth Group
01.2008 - 08.2008
Administrative Assistant
Nucare Pharmaceuticals, Inc
03.2007 - 01.2008
Customer Service Representative
Nucare Pharmaceuticals, Inc
01.2006 - 03.2007
Quality Control Supervisor
Nucare Pharmaceuticals, Inc
09.2003 - 05.2005
License in Pharmacy Technician -
American Career College
High School Diploma - Medical
David Starr Jordan
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