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Cathy Osborn

*** ******** *****, **********, ** 19709 Mobile: 302-***-****

adxyz5@r.postjobfree.com

SUMMARY

Quality Assurance Specialist with experience in document control, developing and implementing effective processes, structure, and customer satisfaction in all aspects of Quality Assurance. A Quality Control background performing raw material, intermediate, and final product testing. Fosters relationships with colleagues and clients with a strong commitment to delivering excellent customer service to support all levels of management. EXPERIENCE

Rogers Corporation OCT 2018 - PRESENT

Quality Assurance Technician - Elastomeric Materials Solutions

- Perform incoming raw materials testing using various instrumentation and equipment.

- Provide accurate and timely test results.

- Maintain quality records, results, and procedures.

- Perform standard testing in a lab environment.

- Certifies physical properties to customers.

- Generates certificate of compliance and distribute to customers.

- Manages/maintains the product retain inventory of test consumables.

- Review compliance of in-coming raw materials to material specifications.

- Perform trials for Engineering department

- Evaluate and resolve instrumentation and equipment issues. Kelly Services Newark, DE NOV 2017 – APR 2018

Records Management Specialist

Hard copy record separation project for intellectual property divesture with compliance to GLP principles

- Reviewed, sorted, and segregated over two thousand mixed laboratory records retained in storage boxes.

- Tracked and recorded storage box locations of records

- Maintained databases, metrics, and hard copy records Fraunhofer USA, Center for Molecular Biotechnology, Newark, DE MAR 2010 – MAY 2017 Senior Quality Assurance Specialist

- Assisted in the process of developing a quality assurance system to ensure compliance to FDA regulatory requirements. Responsibilities included, but were not limited to the following: Metrology and Preventative Maintenance Program

- Reviewed and approved calibration/preventative maintenance documentation.

- Determined the ‘impact’ of metrology failures and assisted in the process of determining actions to reduce the likelihood of future failures.

- Communicated nonconformance/observations to service providers post service.

- Discussed service modifications with providers that Fraunhofer would like to implement and confirmed that modifications were implemented at the next service effort.

- Completed data entry into a tracking system post review and approval of services.

- Filed documentation post data entry.

- Issued reports that provided required service dates.

- Worked with departmental supervision and determined if a management of change compliance form should be initiated when equipment use is required but required service was not completed. Page 2 of 2

Validation Services (IQ/OQ/PQ) instrumental, analytical, manufacturing, software

- Assisted in protocol development (and having knowledge of manufacturing process equipment, facility support systems, and QC analytical instrumentation).

- Participated in protocol execution.

- Completed protocol review and created summary reports. Internal Auditing Program (Internal Document Audits and GMP Inspections)

- Required knowledge of federal regulations.

- Managed the auditing program, developed auditing schedule

- Reviewed audit observations post execution and managed nonconformance issues and resolution.

- Provided QA support during 6 client audits, completing more than 20 internal document audits. Participating in Supplier Qualifications

- Required to determine if suppliers and/or service providers should be defined as “critical” to business operation, and if defined as critical then required transmission of qualification forms.

- Required organizational skills to determine when suppliers and/or service providers require re-qualification. Room Clearance Efforts

- Supported the manufacturing department with efforts to determine if conditions within manufacturing processing rooms complied with established criteria before batch campaign operations were initiated.

- Assisted in the process of nonconformance resolution and provided communication post completion of required efforts.

- Issued batch production records after processing rooms were cleared for batch production service. Document Control Program

- Managed a program that contains hundreds of active documents (completing actions associated with being a

‘Review Group Administrator’ within the document control program).

- Initiated document revision workflows (within a document control program) for documents approaching a procedurally required review date, which enabled Fraunhofer to always maintain the document status as ‘Active’.

- Determined if documentation with a revision process complied with current template requirements (template requirements for QA controlled documents, including standard operating procedures, batch production records, forms, and validation protocols) and if not, revising the document to comply with requirements.

- Maintained the current revision of documentation in distribution locations. Client Requirements

- Scanned batch campaign documentation.

- Assisted with resolving client issues/observations associated with documentation that was transmitted to the client.

- Provided QA support during 6 client audits

Laboratory Notebook Program

- Issued notebooks (notebooks supporting GMP operation and R&D efforts).

- Maintained the notebook program tracking system and issued reports as requested.

- Completed laboratory notebook audits, ensuring compliance, generating reports, and transmitting to applicable managers.

Technical Input/Services

- Provided technical input when compliance issues were identified.

- Assisted in the process of determining the root cause of compliance issues, the impact of issues, and actions to prevent re-occurrence.

Employee Training Program

- Worked with departmental supervision to identify job requirements, issue training activities, and determine if training was completed before procedurally required actions were completed. GMP Compliance/GMP State of Mind

- Assisted Quality Management with promoting and maintaining all compliance systems such that the Fraunhofer CMB Bioprocessing Facility is in an “audit-ready” state at all times.

- Promoted continuous improvement initiatives.

- Determined if new regulations have been issued and/or existing regulations have been revised.

- Promoted and ensured a “GMP State of Mind”.

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