Bethany Bento

-Under the management of the Quality Management System (QMS) Manager, directed and resolved Quality Events (QEs). This includes the summary of the nonconformance, immediate actions taken, findings, impact analysis, root cause analysis, corrective action (CA), preventive action (PA), and effectiveness check (EC).

-Remain compliant with PDMA, FDA and DEA regulations in regard to Standard Operating Procedure's (SOP'S), Business Rule Documents (BRD's), Quality Agreements (QA's), Work Instructions (WI'S), and other regulations and standards as advised including ISO9001.

-Interpersonal relationship building through email and Teams communications

-Assigned investigators to investigate nonconformances as well as drafted technical documents such as deviation reports and trending analysis

-Critical role in forming a deliverable memo to the client of the nonconformance

-Remain compliant with Knipper Health metrics as it pertains to the timeline of the Quality Event

-Assuring that the medical device (stent) passes predetermined criteria according the AQL (Acceptable Quantity Limit) for the batch.

-Extensive use of the Sierra Visicon which analyzes the stent features such as the outer diameter, length, width, and thickness of the stent. The vision take a 360 degree, 2-dimensional image of the stent to be analyzed.

-Quality Inspector for the final packaging of the sterilized medical device pouch. This inspection includes a manual count of each material/IFU that is going with the medical device. The AQL is assessed once more to determine how many final products to inspect.

-Proofread all labels that go on to the medical device as well as in-house products.

-Performed visual inspections using the Sierra Visicon to pass/fail stent parts.

-Maintained high standard of workmanship by abiding only by the approved data, materials, tools and test equipment.

-Reported deficiencies in the stents immediately to assess the issue at hand.

-Communication across all branches of the company to discuss nonconforming product.

-Performed and documented quality inspections and tests in an accurate and timely manner pertaining to in-process and finished goods.

-Maintained a professional understanding or quality requirements and expectations.

-Maintained a safe, clean, and organized production line work area while also abiding with Good Manufacturing Practices (GMP).

-Verified the weight of 30 canisters per hour for a total of 240 products over an 8 hour period.

-Individual batch testing before each sanitized product was run on the line. These tests guaranteed efficacy of the product. The tests included a pH meter, scale, titration, specific gravity, ordour, and visual inspections.

-Adjusted equipment in real time as observed due to being self-motivated with a strong sense of personal responsibility.

-Implemented all new sales and procedures for the front of house at Office Depot.

-In charge of overseeing cash flow and sale operations at cash registers.

-Delegated tasks to existing support team members.

-Resolved all complaints, issues and compliments given to the store from outside sources.

-Organized promotions occurring for Office Depot specials.

-Supervised daily operations and sales functions to maximize revenue, customer satisfaction, and employee productivity.

-Held associates accountable.

-Issuance of all controlled Good Documentation Practice (GDP) documents for pharmaceutical manufacturing site.

-This included verifying all product codes and lot numbers. Routed documents to the correct individuals and uploaded documents accurately.

-Filing of all controlled, confidential, and completed documents concerning ray material to intermediate and final product. This also included stability testing packets.

-Electronic issuance of quality control events such as deviations, extension requests, laboratory incidents, change controls, and other directives as advised.

-Expedited signature approvals for internally produced documents.