Quality Assurance Medical Device

Malinda C Baker

***** ******* **

Gobles, MI ****5

269-***-**** (H)

269-***-**** (C)

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

Quality Documentation Professional

Production and Quality Assurance Specialist

Highly motivated, dependable and seasoned professional with extensive experience driving results in both Manufacturing and Quality Assurance/Control within the Pharmaceutical and Medical Device Industries. A team player that builds effective and productive relationships between customers, clients and co-workers while paying close attention to critical details. Consistently known for willingness to drive and organize projects through completion while striving for excellence with a proven track record of successfully delivering results for Production, Regulatory Affairs and Quality Assurance divisions. This solid foundation in understanding the unique needs and challenges of manufacturing facilities coupled with recently expanded expertise in Quality Assurance affording a unique ability to quickly master and work to improve the most complex business needs including processes, equipment and software for laboratory, supply chain and production use.

Demonstrated success record in:

Distilling value, overcoming objections and securing consensus on complex projects.

Designing quality systems with lean objectives and principles including writing, eliminating, and revising controlled documents and identification of waste in work processes.

Partnering with Business Groups including Operations, Quality, Supply Chain and IT to provide answers and solutions.

Proven Excellence in Leadership and consensus building resulting in high output with less cost and less defects and/or errors.

HIGHLIGHTED CAREER ACHIEVEMENTS

• Lean Manufacturing Principles – Lowered Inspection direct labor hours by 50% through implementing changes to the physical production line while maintaining quality output.

• Standard Operating Procedures – Effectively evaluate, author and revise large volumes of procedures.

• Effective Leadership - Maintained 99% Zero Non-Conformance while managing employees, material and components for multiple medical device product lines.

PROFESSIONAL EXPERIENCE

Manpower Professional – Lansing, MI 2001 – 2010

Quality Assurance Technician II at Pfizer, Inc. in Kalamazoo, MI

• Served as Quality Assurance Technician for Compliance, Complete Document Management, and Analytical Computer Applications for a pharmaceutical manufacturing plant making huge volumes of products for a global market. Driving requests through the lifecycle using approved Standard Operating Procedures (SOPs) for document control. Obtained reviews and approvals, performed necessary electronic revisions, pursued answers to questions quickly and efficiently and tracked requests via database updates through implementation and subsequent record retention.

• Effectively and accurately revised controlled documents and records using complex software systems including LIMS, Documentum/WISDOM, Electronic Change Control (ECC) and Lot Automation System (LAS). Familiar with CLv2. Lead, organized and tracked projects involving large numbers of data records and distributed critical requests reliably for data record changes.

• Recognized as a Pfizer subject matter expert for successful issue identification and resolution for Test Plan creation/revision in the Laboratory Information System.

IMAGYN SURGICAL Richland, Michigan 1985-2000

Division of Imagyn Medical Technologies

Team Leader – Regulatory Affairs Division (1997-2000)

• Developed and managed a Central Incoming Inspection Department supporting multiple product lines, reporting to Quality Assurance Regulatory Manager. Supervised incoming inspection of all raw material orders and inventory. Maintained inventory to ensure productivity of manufacturing lines. Knowledge of Receiving inventory parts and Shipping of end product.

• Responsible for all internal auditing and filing in the Internal Inspection Department. Corrective and Preventative Action Reports. Upheld accurate non-conformance reports, training logs, performance reviews, and attendance reviews. Maintained 99% Zero Non-Conformance while managing four employees, material and components for 15 medical device product lines. Served as Calibration Coordinator to ensure functionality and ISO 9001 standards were maintained with all equipment.

• Responsible for all auditing and filing of Device History Files to maintain FDA and ISO requirements. Suggested, implemented and maintained all procedures within the department ensuring compliance with the CFR. Maintained Document Control for History Files and component files to ISO 9001 and FDA standards. Created and implemented Standard Operating procedures and spreadsheets for the department and Vendor/Customer correspondence.

Production Team Leader – Manufacturing Division (1987-1997)

• Effectively supervised two medical device product lines and a team of forty Inspector/Packers. Successfully implemented changes to production line layout including the performance of production line assemblers resulting in cost savings via reduction of Direct Labor Hours. Interviewed, recommended for hire, and trained new talent. Conducted productive daily meetings to secure consensus on business critical topics such as production changes, customer complaints, back orders, safety, raw material review and metrics. Working knowledge of Purchase orders, Work orders, Bill of materials, raw material inventory, shipping and receiving.

Medical Device Production Line (1985-1987)

Education: Hastings High School Hastings, MI

SKILLS

Microsoft Windows MS Word, Excel, Outlook

Quattro Pro Documented/Wisdom

Keyboarding (70+wpm) Word Perfect Electronic Change Control (ECC)

Material Product Database System (MPSS) Attention to Detail

Laboratory Information Management System (LIMS) Word Perfect

Good Manufacturing Practices (GMPs) Team Player

Hardworking and reliably in attendance

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