Quality Assurance

Shantelle Y. Davis-Beecham

***** ****** **. ****** ******, CA 92555

Mobile: 951-***-****

*****************@*****.***

Highly motivated manufacturing professional with over 8 years of core manufacturing principals with broad experience in fast paced cGMP manufacturing environment. Ability to identify, troubleshoot, and resolve associated issues related to JD Edward System in order to minimize production downtime and increase output. Strengths include attention to detail, organization skills, excellent communication skills, and time management. As well as Strong Analytical skills the ability to Lead others and work in environments with or without supervision. Experience with interdepartmental information exchange with support groups, internal projects with key partners/ contract customers, and the assessment of Inventory Control. CORE COMPETENCIES

• Laboratory Information Management System (LIMS Tracking System)

• Track Wise (Training Records/Global Deviations)

• Hot Dox (Corporate Documentation)

• Device System Inventory (DSI)

• Enterprise Resource Planning System: JD Edwards (Inventory System)

• Active member of the Safety Team Panel

• EPSS

Professional Experience

Burlingame Incorp. Rialto, CA

Quality Assurance Associate 08/2016 to Present

• Process, document, handle and dispose return goods received

• Responsible for the placement of retains on a weekly basis in storage inventory, maintenance of inventory, removal, and disposal per guidelines and procedures.

• Assist in compliance audits

• Trained in daily Environmental Monitoring

• Maintain calibration for all equipment

• Issue asset numbers to new equipment, obsolete and retired/disposed equipment

• Inspection, monitoring, and handling of raw material

• Collaborate with purchasing department to make certain certificate of compliance, of analysis, and SDS’s are obtained from vendors

• Coordinate with Quality control to ensure required release testing for raw materials/ chemicals have been performed prior to release.

Aerotek (Temp Agency) Riverside, CA for Serta Simmons Bedding (Contract) Material Coordinator, 03/2016 to 07/2016

• Highly trained in Quality Control and Inventory Assessments.

• Purchasing Senior Support for Budget and Production Targets

• Followed up with vendors regarding specific issues as needed to confirm corrections have been implemented.

• Processed goods to be returned to the vendors

• Coordinated with accounting department to confirm adjustments

• Work with Management to identify discrepancies during cycle counts

• Managed Physical inventories as needed

• Documents audit findings and utilized data in collaboration with the Materials Manager to generate Corrective Action Reports (CARs).

Watson Pharmaceuticals/Actavis Corona, CA

Manufacturing Data Coordinator II, 01/2013 to 01/2016

• Provided assistance on projects associated with Food and Drug Administration (FDA) audits, Contract Manufacturing Vendors, and Senior Management including multiple building support.

• Assist with training of employees on key Inventory Control programs and software.

• Providing and issuing system ID-cards for employees.

• Provide support to Senior Management collecting information from JDE system and report out findings.

• Managing inventory by controlling/adjusting waste residual.

• Input and close training records utilizing Trackwise Training manager system.

• Format document (s) per redline draft copy in accordance with established procedures.

• Support of data entry of Packaging Downtime Report on a daily basis.

• Support new employee setup (computer and training).

• Initiate change control process for manufacturing/packaging documentation including SOP’s, Batch Records, Forms, and other related documents.

• Prepare BU sample vials and labels for the Quality Assurance/Lab Departments.

• Support with organizing team training for Operations. Watson Pharmaceuticals/Actavis Corona, CA

Manufacturing Data Coordinator I, 11/2008 to 12/2012

• Maintain inventory control for all buildings; assess/correct transaction errors in JDE system thru Work Orders.

• Assist with review of Batch Records; make necessary corrections according to Standard Operating Procedure (SOPs).

• Assist with review, archive of log books, forms, and batch records.

• Provided support to various groups not limited to; Quality Assurance, Manufacturing Operations, Warehouse, Procurement, Planning, Research and Development and Pharm Tech.

• Participate in Kiezen events such as 5S, Continuous Improvements (CI), and Lean Manufacturing.

• Support the site with RFT goal by identifying potential problems. Watson Pharmaceuticals/Actavis Corona, CA

Manufacturing Compression/Tableting Operation I, 05/2007 to 11/2008

• Qualified Process Operator in Compression/Tableting.

• Perform multiple in process tests to ensure quality and compliance was met which including; Friability and Disintegration, Hardness, Thickness, and Weight.

• QA visual inspection of blend material and tablets.

• Trained on electrical and manual pallet jacks

• Ability to troubleshoot and identify potential issues that could adversely impact quality of product.

• Performed multiple activities prior to start-up of operations and post completion which included: Assembly of the Tablet Press, Disassembly, and Tablet Press cleaning and maintenance.

Watson Pharmaceuticals/Actavis Corona, CA/Kelly Service Temp Agency Corona, CA Packaging Operator I, 11/2006 to 05/2007

• Performed general line assembly in a working controlled environment within a team while maintaining quality compliance.

• Performed assembly and disassembly of multiple Packaging Lines in accordance to standard operating procedures.

• Performed cleaning of packaging rooms to maintain compliance and ensure no potential of cross-contamination between lots.

Association for Retarded Citizens Riverside, CA

Group Supervisor, 09/1997 to 09/2006

• Develops and implements activity schedules.

• Skilled in working with individuals of various personality types, physical and mental abilities.

• Assisted people with extensive needs by teaching skills that promoted independence.

• Prepared incident reports for internal agency.

• Experience in completing written logbooks and reports pertaining to the client’s status within the program.

Education

Norte Vista High School – Riverside, Ca

Diploma 1994

Maric College – Riverside, CA

Pharmacy Technician License in 2007

Pharmacy Technician License # 73914

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