Eurofins Lancaster Laboratories

Scientist II Data Reviewer, November 2021 - Present

Accomplishments:

• Substantially rewrote the technical training documents for basic data review to bring them in line with current software and review practices.
• Wrote new training documents for review of chromatographic data and significantly updated existing documentation resulting in a flattened learning curve for new hires to master chromatographic review.
• Selected as the “go-to reviewer” for new data reviewers to shadow, and to provide ongoing guidance and mentoring.
• Created a number of new Excel forms utilizing VBA to track tasks and measurables, resulting in increased efficiency in reviewing mass spec experiments.
• Quickly established a reputation as an excellent communicator on a remote team.
• Selected as the MediaWiki SME to help build the data review team knowledge base.
• Appointed to provide scheduling of review assignments to team when leadership is absent.
• The only Data Reviewer ever to receive a “greatly exceeds” on a performance review.

Duties:

• Review analytical pharmaceutical data to ensure that data is clear, accurate, and complete and that it meets client specifications and regulatory requirements and is of a high quality level.
• Review laboratory notebooks and logs to ensure procedures have adhered to client methods, internal SOPs, and GMP/GLP regulations.
• Authorize certificates of analysis and other client reports to ensure that the reported data meets client protocols and specifications, and ensure the integrity of the final data package.
• Ensure laboratory adherance to GLP/GMP requirements, and apply GLP/GMP in all areas of responsibility as appropriate.
• Perform strategic data analysis and identify patterns to improve metrics.
• Participate in internal investigations and audits to resolve quality issues.
• Update work assignments to team in LIMS system to provide transparency across the organization.
• Identify and recommend continual improvement and lean opportunites.

Software:

• Empower — Used for chromatographic analysis and reporting of results.
• Tiamo — Used to manage titration equipment and data gaterhing.
• Citrix Workspace — Used to access laboratory applications remotely.
• Jira — For issue tracking in chromatography and titration software.
• Microsoft Office — Including Excel, Excel VBA, PowerPoint, Word, and Teams.

Conformance Fasteners

Operations Specialist, July 2016 - October 2021

Accomplishments:

• Redesigned and rewrote process turtles to include a flow chart for greater clarity, resulting in improved training, greater customer satisfaction, and fewer non-conformities.
• Wrote and implemented a style guide for technical documentation, and rewrote work instructions accordingly, increasing clarity and consistency, leading to better training and reducing the number of non-conformities.
• Implemented an online kanboard system to organize and document ongoing short term and long term projects, providing increased transparency and accountability.
• Customized existing bug-tracking software to track 8Ds, eliminating the need for paper or electronic documents, and centralizing the data captured, increasing transparency and accountability, and more efficiently documenting lessons learned and organizational knowledge.
• Implemented an online training system using Moodle, resulting in increased training rates, more efficient on-boarding, and improved data capture and retention, eliminating a perennial nonconformity during annual ISO audits.
• Designed and implemented a highly structured three-week on-boarding and training system to increase retention of temp-to-hire employees, resulting in decreased turnover.
• Implemented, organized, and chaired weekly planning, production, and quality meetings to improve internal communication and collaboration, increase transparency, and reduce miscommunication.
• Redesigned website to increase web presence, which resulted in the acquisition of several new customers.

Duties:

• Audited all new part submission packets to verify compliance to ISO 9001:2015 standards; to customer blueprints, standards, and requirements; and to AIAG PPAP standards.
• Wrote management review for annual ISO recertification audit.
• Updated monthly quality metrics; audited processes quarterly to ensure compliance with internal processes and ISO 9001:2015 standards.
• Trained all new employees and annually re-trained and re-certified current employees.
• Audited outgoing customer orders and approve them for shipment.
• Participated in quality investigations and wrote final reports.
• Designed and implemented poke-yokes as part of CAPAs.
• Provided general IT support.

Software:

• MIsys Manufacturing — Used for purchasing raw material, managing inventory, managing manufacturing process and subcontractors, maintaining controlled lists of suppliers and products, and producing paperwork for customer orders.
• QuickBooks Pro — Used for maintaining customer lists, purchasing MRO materials, and pushing product from inventory to sales to process customer orders.
• Filemaker Pro — Built a database to maintain inspections performed by QC on incoming product.

d12 Web Design and Development

Owner, 2011 - 2015

• Custom web site design and hosting
• Installation and design of content management systems: WordPress, Moodle, MediaWiki
• WordPress theme and plugin development
• Web analytics and security

Fourth Coast Apparel

Co-Owner, 2001-2007

• Graphic design
• Preparation of artwork
• Web design and maintenance
• Sales