Allison Lacina Email & Phone Number

Birmingham, Alabama, United States

Coralville, Iowa, United States

• Proficiently draft and meticulously review internal documents ensuring precision and compliance.
• Actively contribute to the implementation and upkeep of Document Management Systems.
• Execute comprehensive quality reviews of regulatory submission documents.
• Evaluate and grant approval for documentation related to GMP and GLP activities.
• Provide essential QA support for both internal and external audits, regulatory site inspections, change control processes, deviation, Corrective and Preventive Actions (CAPA), and other investigations.
• Ensure compliance with FDA, USP, ISO, internal policy, and other regulatory bodies.

Iowa City, Iowa, United States

• Spearheaded the development and optimization of methodologies, protocols, and training initiatives.
• Designed and executed research and data analysis, presented findings at local and national conferences.
• Oversaw the procurement and management of essential equipment, software, and supplies.
• Recruited, trained, and supervised a proficient team of personnel.
• Maintained rigorous adherence to regulatory guidelines including IRB, FDA, and USDA.
• Demonstrated adept project management skills, fostering direct communication with external stakeholders to ensure transparent progress reporting and adherence to established timelines.

Coralville, Iowa, United States

• Collaborated with staff in the development, validation, and implementation of methodologies, procedures, and policies pertaining to safety, security, and testing protocols.
• Trained, supervised, and managed staff scheduling within a CLIA-regulated environment.
• Conducted internal audits to ensure compliance with FDA, HIPAA, and CDC regulations.
• Managed the receipt and accessioning of patient samples.
• Processed patient samples in a BSL-2 environment.
• Executed qPCR assays for the detection of SARS-CoV-2 and reported results to governmental entities, including state representatives and the CDC.

Greeley, Colorado

• Supervised and trained personnel in a high throughput testing environment with strict deadlines on aseptic, microbiological, molecular, and sanitization methodologies in compliance with FDA, USDA, ISO, and GLP.
• Ensured proficiency in multiple departmental operations, including sample preparation, pathology, microbiology, media, transportation, and sanitization.
• Performed comprehensive testing and meticulous documentation of food products, ingredients, and environmental samples, employing diverse testing methodologies.
• Effectively reported results to clients in a professional, confidential, and prompt manner.
• Oversaw the calibration and maintenance of equipment, ensuring accuracy and reliability.
• Contributed to procedural management, method validations, and engagement in research and development initiatives.

Longmont, Colorado, United States

• Ensured compliance with regulatory guidelines set by ATF, FDA, USDA, State Alcohol Beverage Control Boards, and local health departments.
• Conducted aseptic sample collection and filtration, qPCR, microbial identification, cell viability and vitality testing.
• Executed daily quality control analysis of Vicinal Diketones, Acid Aldehyde, colorimetric, enzymatic, pH, ABV, dissolved oxygen, carbon dioxide, and turbidity of finished and in-process products.
• Performed environmental water testing to ensure compliance with state and local regulations.
• Managed the calibration and upkeep of various specialized instruments, including GC-MS, qPCR machines, Alcohol Analysis equipment, and automated cell counting devices.
• Managed daily sensory panels evaluating both existing and R&D products, while also taking the lead in conducting extensive cross-departmental training sessions that emphasized product description and authentic taste.

Greeley, Colorado

• Conducted comprehensive testing and meticulous documentation of food products, ingredients, and environmental samples, employing diverse testing methodologies.
• Effectively reported results to clients in a professional, confidential, and prompt manner.
• Ensured proficiency in multiple departmental operations, including sample preparation, pathology, microbiology, media, transportation, and sanitization.
• Trained personnel in a high throughput testing environment with strict deadlines on aseptic, microbiological, molecular, and sanitization methodologies in compliance with FDA, USDA, ISO, and GLP.
• Contributed to procedural management, method validations, and engagement in research and development initiatives.
• Performed QC of documentation, raw data, and testing protocols.

Minneapolis, Minnesota

• Orchestrated end-to-end processes, including assembly, calibration, packaging, shipping, and installation of comparison and compound microscopes for both clients and demonstrations.
• Developed comprehensive QC and training programs encompassing system use, calibration, maintenance, and specialized software.
• Ensured compliance with ATF, NIST, ISO, and ANSI-ASQ National Accreditation Board (ANAB) regulations through ongoing regulatory review to facilitate audits.
• Collaborated with sales team and clients to resolve system issues and identify avenues for product development.
• Spearheaded multidisciplinary teams comprising of software specialists, engineers, and manufacturing experts, sales, and clientele on R&D projects to drive innovation.

Cedar Rapids, Iowa Area

Cedar Rapids, Iowa Area

• Provided compassionate care to a diverse patient population in intensive, psychiatric, and emergency care settings, fostering a safe, respectful, and confidential atmosphere.
• Exhibited exceptional proficiency in emergency preparedness and response, consistently maintaining composure and efficiency in high-pressure scenarios.
• Provided consistent communication and meticulous documentation of patient status, activities, and daily care.
• Performed aseptic procedures and specimen collection.

Cedar Rapids, Iowa Area

West Branch, Iowa