Donna Cox Email & Phone Number

Troy, Nc, Us

Asheboro

All duties are administered according to the standards set forth within 21 CFR Part 820, ISO9001 & ISO13485. Coordinate activities supporting the nonconformance process. Conduct nonconformance activities as needed to ensure timely completion of action plans and generation of accurate records. Perform analysis, trending and reporting of nonconformance trends across products, facilities and functions. Maintain CAPA and SCAR systems. Administer quality system document changes and the release of new or revised documents for the Asheboro facility. Maintain the quality training program including training requirements, the training database and training files. Perform employee orientations, quality training and audit support. More specifically:* Distribute documents according to standard procedures.* Maintain the Controlled Document Records.* Issued and distribute monthly maintenance records.* Execute ECRs and ECOs in the ERP system. * Review external document changes and translate these changes into applicable requirements for the Asheboro facility.* Track records that are checked in and out of the Document Control Center.*Advise on required training for revised or new training documents such as work instructions or SOPs and manufacturing qualification forms. Ensure all new documents have properly completed training audience form and approve change requests with attached training requirements in the facility database. Ensure each new employee or employees new in position receives a copy of all required training requirements for their position.*Prepare and facilitate training programs such as Annual Quality Training and classroom training to newly hired employees. Create and update training plans for new positions, position changes and title changes in facility database.* Perform process audits within the internal audit program as directed by the Internal Audit Leader. Audit to the 21 CFR Part 820 ISO-001 & ISO13485 standards.

Asheboro, Nc

All duties are administered according to the standards set forth within 21 CFR Part 820, ISO9001 & ISO13485. I administer quality system document changes and the release of new or revised documents for the Asheboro facility. Maintain the quality training program including training requirements, the training database and training files. Perform employee orientations, quality training and audit support. More specifically:* Distribute documents according to standard procedures.* Maintain the Controlled Document Records.* Issued and distribute monthly maintenance records.* Execute ECRs and ECOs in the ERP system. * Review external document changes and translate these changes into applicable requirements for the Asheboro facility.* Track records that are checked in and out of the Document Control Center.*Advise on required training for revised or new training documents such as work instructions or SOPs and manufacturing qualification forms. Ensure all new documents have properly completed training audience form and approve change requests with attached training requirements in the facility database. Ensure each new employee or employees new in position receives a copy of all required training requirements for their position.*Prepare and facilitate training programs such as Annual Quality Training and classroom training to newly hired employees. Create and update training plans for new positions, position changes and title changes in facility database.* Perform process audits within the internal audit program as directed by the Internal Audit Leader. Audit to the 21 CFR Part 820 ISO-001 & ISO13485 standards.* Complete the Purchase Requisitions for the department using SAP.

Asheboro

* Identify and generate non-conformance in SAP.* Assign/complete task associated with the non-conformance which may include but are not limited to: *Place kit on hold. *Assign Severity Level *Investigate Issue *Root cause & Trending *Corrective Action*Complete necessary forms associated with the NC. (Example R-007, RAQA-F209, etc.)*Investigate and research missing or inconsistent information*Collaborate with other department personnel in order to ensure accurate information is recorded in non-conformance*Assist with training employees pertaining to non-conformance*Complete and maintain the Metrics-Packaging rework

Asheboro, Nc

Associate'S Degree, Business Administration And Management, General

Bachelor'S Degree, Management