Tracey J. Email and Phone Number

Initiate change controls; write procedures / work instructions as needed for all departments; assist as change control analyst; assist all departments with SOP Manual updates; assist Supervisors with Training Program; provide training reports from OLM; assist in Audits; control the Deviations, CAPA, and NCMR's; provide status / monthly reports on deviations, CAPAs, and NCMR's from Agile;

Primary Functions• Maintains internal and external customers current specification revision and communicates to other plant personnel.• Maintains internal and external document control logs.• Identify any necessary deviations for corrective action.• Maintains records and files for Good Manufacturing Practices.• Writes, reviews, and implements new documents under the direction of the Quality Manager. • Performs revision changes to current documents and disposes of expired documents.• Works closely with other departments to facilitate the total quality function by completing, assisting in directing, and participating in internal audits.• Identifies any deviations for corrective action and follows up for closure.• Assists in the necessary activities relative to internal and external customer complaints, audit and disposition of goods, corrective action, and documentation.• Assists in training all new and existing quality personnel on new and revised documents.• Assists with training all new and existing plant personnel on current Good Manufacturing Practices.• Assists in developing and maintaining label control procedures and identifies deviations for corrective actions and follow up.• Reviews new and revised customer specifications and product drawings for identifying any necessary additions or alterations to existing tooling, techniques, procedures, or other normal operating procedures.

Job is the same as it was with Haemonetics.

• Compile all batch record documentation in preparation for product release for the site. Ensures information is all present, accurate and meets the product/GMP requirements prior to release. • Process procedural revisions and protocols, track approval process, place revised documents in appropriate manuals and retrieve obsolete documents. • Issue all batch related investigations and non-conforming reports, track approval process and control distribution of reports to appropriate personnel. • Prepare, issue and distribute Manufacturing Work Orders and batch record documentation to manufacturing and laboratory departments.• Generates and issues labeling for manufacturing process.• Final review and disposition of sterilization cycles and batch records for release of product. Required to investigate and report any discrepancies or issues. Performs chemical and component reconciliation and review prior to release of product.• Prepares Certificates of Analysis for finished products. Maintains the on-line database for product certificates.• Responsible for final release and distribution of batch documentation of finished products.• Ability to make decisions based on objective data rather than subjective opinion.• Superior documentation skills are required. The ability to provide clear, accurate written descriptions of events and findings.

Responsible for the statistical sampling and assessment of the manufacturing process. Samples are collected at various stages of the operation and tested for compliance to product specifications. In addition, responsible for sampling and testing incoming components and packaging materials. Raw material chemicals are examined and sampled for laboratory analysis. Issued Material Evaluation and Out-of-Limits Reports and system related documentation. Responsible for PIR investigations. Investigates and responds to plant PIRs. Examine returned product, determine rootcause and provide the plant response.

Followed documentation and supervisor’s direction to efficiently build high-quality products. Specific job tasks included operation of automatic equipment, sanitation of work area and completion of appropriate documentation. Assured adequate seals on overpouch product to eliminate vacuum loss rejects at time of packing. Followed good documentation practices to build high quality product per SOP’s. Inspected product for rejects including leakers, illegible label copy, missing components, etc per SOP’s. Labeling and sampling of samples for Quality Assurance including product bioburden, chemistry, LAL/PM, etc. Loaded sterilizer carts per validated cycle configurations per SOP’s. Operated equipment such as Filling Machines, Overpouch Machine and Pallet Jack. Performed line clearances between batches. Sanitized work area as per SOP’s. Set-up Filling Machines for appropriate weights per the Manufacturing Work Order.

7th grade mathematics, 8th grade mathematics, and Algebra I Honors