Thea Joy Paras

QA Validation Analyst specializing in process, cleaning, and hold-time validation across solid oral and suspension manufacturing lines. Demonstrated success in introducing Health-Based Exposure Limit (HBEL) methodologies, revising site Master Plans and SOPs to PIC/S standards, and developing compliant spreadsheet models for swab limit calculations. Backed by a strong foundation in microbiological bioassays and analytical instrumentation.

Quality Assurance Validation Analyst I at JM Tolmann Laboratories Inc. (2026-02 – Present)

Transferred from Quality Assurance Inspectorate after 4 months.

• Author validation protocols (25 drafted) and execute closure reporting (10 completed) across solid and liquid dosage forms while evaluating process capability parameters (CpK, SD, %RSD) for weight variation, dosage unit uniformity, and assay as well as the product's critical process parameters.
• Pioneer the facility's first Health-Based Exposure Limit (HBEL) and MACO cleaning validation study (1 report closed) and validate a compliant Excel calculation model to automate swab limit determinations and safeguard data integrity.
• Formulate hold-time protocols (6 drafted) and close final validation reports (3 completed) to establish chemical and microbiological stability limits for bulk in-process materials.
• Revise the site Cleaning Validation Master Plan (CVMP) and core Process Validation (PV) and Cleaning Validation (CV) SOPs, aligning facility practices with PIC/S guidelines and directly satisfying audit CAPA commitments.
• Administer Change Control and Failure Mode and Effects Analysis (FMEA) risk registries while authoring technical audit responses and root-cause analysis records for site CAPA action plans.

Quality Assurance Inspectorate at JM Tolmann Laboratories Inc. (2025-10 – 2026-02)

• Conducted in-process quality control inspections, line clearance verifications, and batch production record reviews across manufacturing operations prior to internal promotion to QA Validation.

Laboratory On-the-Job Training - Biomedical Research Section at Philippine Nuclear Research Institute (2023 – 2023)

• Executed routine microbiological testing—including antimicrobial assays, accelerated aging tests, and sterility evaluations—in strict adherence to standardized research protocols.
• Formulated microbiological culture media and prepared test samples utilizing aseptic transfer techniques, precise volumetric measurements, and pH verification protocols.
• Operated and maintained specialized analytical and laboratory instrumentation—including microplate readers, rotary evaporators, sonicator baths, autoclaves, and incubators—following standard work instructions.
• Analyzed, tabulated, and documented experimental datasets for research manuscripts and service deliverables while upholding strict data integrity standards.

Bachelor of Science in Biology – Rizal Technological University (2020 – 2025)