Teresa Becker

Email: abo6r8@r.postjobfree.com

Address: ****-**** ******

City: Kenosha

State: WI

Zip: 53142

Country: USA

Phone: 262-***-****

Skill Level: Experienced

Salary Range: 60

Willing to Relocate

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

TERESA BECKER

7948 39th Avenue

Kenosha, Wisconsin 53142

262-***-****

abo6r8@r.postjobfree.com

BACKGROUND SUMMARY

Operations Professional with extensive experience in diverse areas of healthcare manufacturing. Strong analytical skills and attention to detail that result in effective issue resolution and customer satisfaction. Expertise in:

. Team Leadership

. Quality

. Clinical Trials

. Product Labeling

. Regulatory Compliance

. Project Management

. Training

. Change Control

PROFESSIONAL EXPERIENCE

ABBOTT LABORATORIES, Abbott Park, IL 1999 to 2012

Technical Support Scientist, Abbott Diagnostics 2007 to 2012

Responsible for authoring and processing changes to device master record and quality system documents.

* Analyzed manufacturing formulas and device master records, implementing changes to ensure compliance with FDA, DEA and ISO requirements.

* Participated on team to track and review procedural errors, implementing processes that significantly reduced rejection rates.

* Key member of cross functional process improvement team to transfer documents during plant closing, ensuring smooth transition within deadline.

* Managed design and process changes for product manufacturing, expediting resolution of technical issues to ensure product availability.

* Created and implemented instructor led and online training for product labeling and inserts, enhancing skills to increase efficiency and reduce costs.

Labeling Coordinator, Abbott Diagnostics 2004 to 2007

Responsible for coordinating all aspects of product labeling.

* Communicated and coordinated approval with global and domestic locations to meet production timelines and ensure accurate inventory levels.

* Managed, initiated, reviewed and approved labeling change control documentation/specifications, expediting issue resolution to reduce costs.

Proofreader, Abbott Diagnostics 2001 to 2004

Responsible for proofreading, typeset of copy final product labeling and managing change control packages for product labeling.

* Utilized multilingual application to proofread product inserts and labels, ensuring appropriate changes needed for product availability and quality.

* Processed changes to labels and package inserts and developed standard operating procedures in compliance with corporate and federal regulations.

Clinical Supervisor, Global Pharma Research and Development 1998 to 2001

Managed 18 employees to conduct clinical studies for FDA approval.

* Identified job function training requirements and developed targeted performance plans, providing coaching that enhanced teamwork and improved productivity.

* Conducted facility audits and ensured compliance with general manufacturing practices through implementation of appropriate operating procedures, study specific protocols and OSHA practices.

* Acted as Controlled Drugs Agent with accountability for development of narcotics products, ensuring appropriate and timely approvals in compliance with FDA regulations.

Prior to 2001

Held progressively responsible positions as Auditor, Clinical Dispenser and Production Worker.

CERTIFICATIONS

Control Drug Agent

PROFESSIONAL DEVELOPMENT

Business Processes

Project Management

Effective Communication

Managing Conflict

Human Error Reduction

Process Improvement

TECHNICAL SKILLS

Word, Excel, PowerPoint, Adobe Acrobat, Lotus Notes, Document Management System, Electronic Change System, Inventory Management System, Clarity

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