Melissa Lantagne

• Supports investigations using problem-solving tools as the owner or Quality Assurance (QA) Approver

• Assists in the execution and closure of corrective actions change controls to address deviations from GMP standards

• Review and QA approve GMP master documents and executed GMP documents from various departments including Quality Control, Manufacturing, Material Management, Facilities and Engineering, and others involved in lot production.

• Takes responsibility for the generation, inspection and release of labels to ensure compliance with regulatory requirements

• Conduct Quality Assurance review and approval of GMP documents such as master documents, executed documents, and quality system records including change controls, deviations/investigations, Corrective and Preventative Actions (CAPAs), and controlled documents.

• Collaborate closely with manufacturing and support groups to conduct QA walkthroughs and address any issues identified during the process

• Reviews and approves GMP documentation generated as a result of manufacturing activities, including batch records, forms, logbooks, and work orders to ensure accuracy and compliance with GMP standards.

Prepare, distribute, and archive documentation and information as necessary; manage structure and content in file management drive.

Assist in investigating and correcting quality-related issues (including customer complaints) through collaboration with other departments

• Managed the successful completion of multiple simultaneous projects while maintaining strict deadlines and high-quality outputs.
• Ensured compliance with industry standards by staying up-to-date on relevant guidelines, policies, and regulations affecting QC operations.
• Assisted in the performance and documentation for environmental monitoring of clean rooms and water systems in compliance with Standard Operating Procedures.
• Performed Environmental and Utility monitoring.
• Performed testing in support of facility Validation activities
• Reduced production errors by closely monitoring product specifications and identifying areas for improvement.
• Read and interpreted environmental monitoring data generated in various areas of Manufacturing
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• Maintained a clean and organized work environment, adhering to best practices for laboratory safety and hygiene.
• Conduct routine sampling of raw materials according to established sampling plans and schedules.
• Assisted in the performance and documentation for environmental monitoring of clean rooms and water systems in compliance with Standard Operating Procedures.
• Performed microbiology testing in a timely fashion, while maintaining a high level of quality work
• Perform visual inspections of incoming raw materials to assess their quality and integrity.
• Utilize appropriate sampling techniques and equipment to collect representative samples for testing
• Conducted Environmental and Utility monitoring. Performed testing in support of facility Validation activities
• Conducted Environmental monitoring of Aseptic Production
• Read and interpreted environmental monitoring data generated in various areas of Manufacturing
• Ensure proper labeling and documentation of sampled materials, including accurate recording of sample information and batch numbers.
• Performed microbiological testing (endotoxin, bioburden, TOC, conductivity) for water

• Collaborated with cross-functional teams to ensure seamless communication and efficient completion of tasks within the cleanroom environment.
• Maximized productivity by efficiently prioritizing tasks while working independently or as part of a team under minimal supervision within the cleanroom setting.
• Sanitized Clean Room Facilities with an emphasis on the prevention of infectious bacterial, and fungal growth
• Reviewed that the handling of cleaning chemicals used during sanitation met EPA and GMP compliances
• Responsible for the preparation of cleaning/sanitizing solutions and materials to specifications
• Identified and communicated any material or procedural discrepancies
• Accurately documented solution prep and cleaning activities in logbooks according to Good Document Practices (cGMPs)
• Adhered to all regulatory and compliance requirements defined in Good Manufacturing Practices (cGMPs)
• Read, followed, and executed client's Standard Operating Procedures (SOPs)
• Provided support for internal and Regulatory Inspections

• Enhanced product usability by identifying and resolving software issues.
• Displayed courteous and strong interpersonal skills with all customer interactions
• Researched issues on various computer systems and databases to resolve complaints, answer inquiries, and outline solutions.
• Trained new employees on systems and protocols
• Kept customers informed of progress during the issue lifecycle and made follow-up calls or communications in a timely manner.
• Maintained updated knowledge of company products and services to better provide customer support and service solutions
• Accessed documented procedures tools and manuals to provide support on company supplied hardware and equipment
• Accurately processed and documented call transactions using tracking software
• Gathered customer and technology information to determine technical support level; elevate calls to the appropriate support level as necessary.
• Established patterns to reoccurring issues and provided input to development teams.
• Participated in product testing phases, ensuring optimal functionality prior to release dates.
• Communicated critical product updates to customers, minimizing disruptions during implementation phases.
• Developed custom solutions for clients, resulting in higher satisfaction rates and retention.