Sara Wallace Email and Phone Number

I do photography as a hobby and offer portraiture services, photo restoration and editing, and personal art work for purchase. In addition to artistic endeavors, I enjoy practicing creativity in entrepreneurship, marketing, SEO and website design (UX), and printing. Visit my website at sarawallaceimagery.com.

Key accomplishments included: 1) Managed implementation of a cGMP temperature excursion studies program with Process Development and Quality Engineering teams, 2) Led efforts to reduce labor hour and financial variances with our Planning, Product Engineering, and Operations teams using data from Oracle. 3) Served as Lead Auditor for internal audit of our Preventive Maintenance Program, as well as Supporting Auditor of multiple other internal audits.4) Served as Project Manager for a site-wide Data & Metadata Integrity Kaizen.Responsible to:- Autonomously maintain QC testing and documentation for assigned serum and media product lines, and maintain both active and cryopreserved stock populations of mammalian BSL I-II cell lines in a sterile environment, all according to ISO13485 and cGMP protocols. - Support all QC/QA and EHS activities applicable to assigned lab work, for example: CAPA and non-conforming product investigations, technology transfers and reporting, new employee training, laboratory area and equipment maintenance, weekly Quality walk-throughs, internal/external audits, hazard assessments, kaizens, etc.- Help to improve or create laboratory documentation, processes, and training resources, participate in kaizens and troubleshooting, and to similarly further the continuous improvement of applicable QMS procedures, safety policies, and related as needed.- Assist and provide design feedback for a new LIMS database in development. Also to regularly use a variety of other applications, including Master Control, Oracle, TrackWise, GenSuite Inspection Tools, Application Extender, Colab, GE Box, and Kronos.

Key driver in implementing and maintaining first-time ISO13485 registration and cGMP compliance (transitioning from ISO-9001) in a LEAN medical device manufacturing environment. Was also responsible for various QC assignments, such as final and in-process product testing, analysis of incoming materials, approving batch records and labels, instrument calibration and maintenance, final product inspection and packaging, and handling of non-conforming or returned product. - Designed & updated many R&D and QC test and technology transfer procedures and documentation, data analysis methods, product specifications and Pass/Fail (P/F) criteria, - Assisted in devising, negotiating, and writing/editing cross-functional improvements in QMS/TQM policies and protocols, manufacturing process controls, equipment maintenance, metrics for management review meetings, data & record management practices, Product Design Control, and Product Change Control. - Authored a wholly-new software update validation protocol and customer complaint tracking system, along with a majority of the necessary files & resources, including internal training materials. - Served as Document Administrator using Paradigm document management/compliance management software, helped to issue and verify CAPAs, perform document root-cause analysis and product failure investigations, execute gap analyses and risk assessments, and manage job descriptions and digital training records. - Performed regular lab maintenance inspections, and supported both internal and external audits. Served as Internal Auditor for a variety of ISO9001/ISO13485 units, including R&D, Production, Quality, Inventory & Warehousing, Accounting & Finance, etc.

Designed and lead the first formal Technical Customer Support program at global company, and solely managed all technical communications for customers and distributors. - Traveled internationally and presented many live seminars, webinars, and trainings. - Implemented a new ISO13485 and cGMP -compliant customer feedback & complaints process utilizing a variety of software, such as Salesforce, MyEmma, Microsoft Office, and Paradigm. - Authored and/or edited a majority of the company’s internal and external technical material, including authoring the company's online "Tech Tips" which brought the most website visits to the company's website for several years running, reworking their entire Q-View Software Users Manual, and contributing major improvements to various SOPs, controlled forms, data analysis and reporting templates, product manuals, internal wiki and training materials, and marketing and customer collateral.- Worked directly with global customers daily to resolve problems via email, phone conferences, live chat, and face-to-face (f2f) interactions, coordinated troubleshooting and communication efforts of appropriate sales and R&D or QC personnel. - Collaborated on software development to optimize the Q-View Software(TM) GUI and algorithms; authored the first software update release procedure and resources.- Regularly provided training presentations, workshops, and webinars for employees, international distributors, customers, and conference attendees.- Influenced company policies relating to customer interactions and training, sales & marketing resources, management review of market feedback, customer complaints, CAPAs and audit findings, etc.Note: I fulfilled this role simultaneously to serving as either R&D or Quality Technician at Quansys. I LOVED wearing many hats within the company, learning about and supporting business administration first-hand, and actively influencing positive change and culture between teams and departments.

Responsible for diverse product and process development activities, including:- Development, validation & verification (V&V), and transfer of new custom multiplex ELISA (protein assay arrays), and lab imager & software products through recovery and linearity, accuracy, precision, and stability testing. Designed experiments, statistical analysis, and compiled design history files (DHF). - Facilitated Technology Transfer to Production, QC, Sales/Marketing, and customers, and assisted with design of product launch marketing and labeling materials as needed. Created and implemented the company's first standardized product development analysis and reporting templates for internal and external use and also their first formal internal tech transfer protocols.- Authored and edited standard operating procedures (SOP's), experiment and manufacturing forms, work instructions (WI's or WID's), training and marketing materials; also responsible for creating and maintaining complex data analysis templates e.g. in MS Excel, and various data report & presentation templates, e.g. in MS Word, Powerpoint, etc.- Regularly interacted with customers and global contacts to update them on project progress via teleconference, email, and document sharing applications.- Optimized existing products, manufacturing processes, and data analysis methods, Q-View Software and Imager functions, training protocols, and facility layout and organization. Served on Continuous Improvement Committee, Internal Audit Team, and similar; also discovered and addressed deficiencies in sample testing procedures and documents.- Investigated new and innovative technologies and methods, also frequently researched and collaborated on cross-functional improvement projects.- Designed and conducted studies for product, process, and software improvement (DOE).- Trained new hires for all Operations and Sales/Marketing Teams. Also assisted with improving various onboarding processes and policies.

Studied Mutations of Critical Amino Acids in PTPs: Prepared mutant enzymes of the human enzyme Protein Tyrosine Phosphatase 1B, which is a prime research target for disease prevention. Compared the kinetic and structural consequences of mutations to two amino acids that are involved with active site loop movement and found that these amino acids must be critical to enzyme function, as their mutation results in reducing kcat by 3-5 orders of magnitude.

• Amide Cleavage Study: Synthesized, purified, and characterized a novel zinc(II) complex as a model for enzymes which cleave amino acids. Results provided evidence that secondary hydrogen bonding in the ligand effects the formation of the metal complex. Completed USU’s Lab Safety Course. • Reactivity of a Cadmium Hydroxide Complex with CO2: Synthesized and characterized a Cd-OH complex as model of a novel carbonic anhydrase and investigated its reactivity with CO2. Helped prepare the results for publication in Dalton Transactions. Results showed that the Cd-OH complex is a good model of the enzyme CDCA1, in that it reacts with CO2 to form a Cd-CO3 complex, but unlike the enzyme, the model forms a dimeric product and cannot perform the reverse reaction.• Aqueous Chemistry of a ZnII/ZnII Model for Glyoxalase II: Synthesized an organically-ligated dimeric ZnII/ZnII complex and investigated it’s 1H NMR, solubility, and acidity. This model for Glyoxalase II may have applications to chemotherapeutic and anti-malarial pharmaceuticals.