Remi Galestanian

(Leave of absence: Dec 2024 – Feb 2025 due to a significant family loss)

• Served as primary reviewer of stability study results: verifying raw data, ensuring report accuracy, and collaborating with other departments to resolve discrepancies.
• Monitored incoming client emails and responded promptly to maintain clear communication and support ongoing project timelines.
• Communicated directly with clients to resolve discrepancies between submitted products and accompanying documentation.
• Consistently followed up with clients and coordinated with internal teams to ensure timely resolution of documentation issues to prevent delays in testing.
• Utilized Qualtrax to review and approve Out-of-Specification (OOS) results to minimize any internal testing errors prior to notification of the client.
• Ensured timely set up of new stability study projects in accordance with GDP standards and protocol guidelines.
• Prepared daily stability submission forms to be distributed to the applicable testing departments.
• Guaranteed the prompt delivery of test results to clients by routinely updating and managing team calendars.
• Maintained expertise in LIMS for accurate sample entry and data management.
• Trained new team members on key documentation tasks and lab systems to avoid inconsistencies in workflow and performance.
• Drafted and revised protocols in collaboration with supervisor, ensuring alignment with internal procedures, QA guidelines, and client-specific testing requests and specifications.

• Prepared and administered medications including intramuscular, intradermal, and subcutaneous injections.
• Performed phlebotomy including: collecting blood specimens and sputum, urine, throat swabs, and swabs of other infected sites.
• Promoted office efficiency by managing medical records, coordinating charts, and scheduling appointments/registering patients.
• Directed patients to exam rooms and fielded questions, all while collecting and documenting patient vitals and other medical information.
• Attended to diverse patient needs and maintained a compassionate environment to ensure that they feel at ease and cared for.

• Performed essential routine assays for analysis of pharmaceutical products such as: protein concentration/content determination, pH determination, measurement of opalescence, and visual analyses for particles and lamellae. Also performed routine assays for water sample testing including conductivity and Total Organic Carbon determination.
• Followed strict GDP and GMP guidelines, Standard Operating Procedures, and written methods per USP, EU, and JP compendia.
• Excelled in duties outside of the laboratory including: data entry in Laboratory Information Management Systems, supporting documentation of deviations, CAPAs, ARAs, method transfer and validations, and meeting demanding testing deadlines while completing projects both inside and outside of the lab.
• Supported proper investigation of OOS results or equipment malfunctions by following protocols and guidance from management.