Sana Biotechnology, Inc.

-Support management and leadership of QC laboratory and GMP testing readiness.

– Support establishment and maintenance of QC labs (lab organization, instrument/equipment calibration, preventative maintenance, lab cleaning, etc).

-Work with vendors or internal team to get CoA, CoC, product specification documents for raw materials, consumables, or equipment.

– Write material specifications based on above information.

- Create Raw Material Risk Assessments for products to be reviewed by upper management to be used for upcoming studies/projects.

-Organize release and stability data into Excel sheet or database.

-Support internal teams for QC GMP sample shipment and warehouse activities.

Quality Control

Labcorp

QA Compliance Specialist for Monogram Biosciences - LabCorp Specialty Testing Group

• Maintenance of Monogram's controlled documentation systems including our electronic documentation system (MasterControl), controlled document master files, controlled document manuals (SOP Binders) and associated processes required for the effective maintenance and continued improvement of the document control system.
• Processing and technical editing of controlled documents according to Monogram's controlled document templates, reference policies, and procedures. Including the processing of various documents such as SOPs, Forms, Tickets, Process Flows, Policies, Validation Protocols and Reports and other controlled documents.
• Maintaining effective management of the documentation requirements for projects and high-priority company goals and plans. In collaboration with QA management, performs comprehensive analysis of documentation requirements and close collaboration with key document reviewers from various cross-functional groups to ensure efficient and timely approval of all required documents using the MasterControl(QMS) system.
• Participation in QA group planning and goal setting. Provided  training and support to other QA groups. In collaboration with QA management, participated in the development of Quality Initiatives and the execution of Monogram's Quality programs. These activities include participation in internal audits, client or sponsor audits, personnel training files audit and trending/reporting of quality metrics.
• Assigned as the primary support for the Monogram Audit (Host) Team; coordinating with other functional areas to obtain materials, documents, records and other similar references requested during audits and inspections.

QA Compliance Specialist

Contacted for LabCorp.

-Sample inventory, segregation, filing, and storing of HIV/HCV plasma, plasmid samples. Sample request retrieval and sample destruction. 

-Double Data Entry for Test Request Forms (TRFs) after sample accessioning (Averaging about 100 TRFs per full day shift) and making corrections on 3G. 

-Management of freezer space of sample storage as well as taking temperatures of the freezers in which HIV/HCV samples are stored.

-Assembly of QA controlled documents such as validations, equipment qualification (IQOQPQ). 

-Assembly of PR-RT and Cell Assay batches. Reviewing batches and performing Final Review on corrected batches.

-Archival of records of equipment logs, viral load logs. 

-Creating folders for new Equipment Management System (EMS) records, reviewing of maintenance company’s regulatory and laboratory batches and documentation. 

-Managing the Controlled Documentation Room (CDR), maintaining Occurrence Reports. 

-Creating employee training files and sorting and filing training files.

Quality Assurance Coordinator

Norman M. Golden, EA

- Help with internal and external audits as required.

- Provide support to internal business partners.

- Verify, log and mail checks, including expediting special handling.

- Carry out daily processes and controls accurately and on time, and ensure compliance with company policies.

- Handle daily department mail by opening, sorting, and distributing it.

- Assist the AP/Finance Department with administrative tasks.

- Sort, log, scan, and file invoices, checks, and other documents.

- Complete special projects on an as-needed basis.

Administrator

PSCU

-Placed outbound calls, respond to inbound calls, and analyzed debit and credit card transactions in order to identify potential fraudulent activity via the Falcon Fraud Detection System.

-Reviewed electronic cases produced by the Falcon Fraud Detection System.

-Represented the department professionally in talking to internal and external customers in an inbound/outbound call center.

-Analyzed transaction patterns and respond quickly to high-risk situations.

-Identified changing fraud trends, document and report to appropriate department personnel in a timely manner to assist in the reduction of fraud loss.

-Verified account activity and take appropriate actions to minimize potential fraud loss and customer inconvenience as well as controlling and managing calls.

-Process Lost/Stolen account calls.

-Maintain daily and monthly performance standards, including those pertaining to quality and quantity.

-Perform all other miscellaneous duties as assigned.

Fraud Detection Representative

OneAZ Credit Union

Jumbo CD Investments, Inc

Executive Assistant

First Tech Federal Credit Union

Member Services Representative

✨ “The nitrogen in our DNA, the calcium in our teeth, the iron in our blood, the carbon in our apple pies were made in the interiors of collapsing stars. We are made of star stuff”. ✨– Carl Sagan

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