Stability and Regulatory Associate Resume Example
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STABILITY AND REGULATORY ASSOCIATE
Professional Overview
Over twenty five years of pharmaceutical experience in the Quality Laboratories and Quality Services including 9 years of stability experience As a stability scientist main responsibility is to determine the appropriate shelf life/ expiry period and label storage statement for clinical and finished products such as drug products, cosmetics and medical devices. Oversees all aspects of the stability program from initiating stability study, preparing portions of regulatory submissions to commercial launch. Investigates quality issues, determines root cause, and initiates corrective action with the guidance of local and regulatory documents as well as other groups such as, Quality Assurance and New Product Development Group, when required.
As a senior scientist in quality control, responsibilities were to managed workflow, created and implemented changes in processes for more efficient and compliant practices by proper documentation from sample receipt to sample destruction. Managed the upgrade of monitoring system for environmental chambers to a CFR 21 system. Migrated stability studies from manual system to the electronic system, which led to efficient timelines in stability study initiation, reduced missed pulls and deviation Trained colleagues on the use Laboratory Information Management System and other specialty equipment such as the particle counter.
Core Qualifications
| Laboratory Information Management System (LIMS), Non-Conformance Software (TrackWise), Documentum, Laboratory Automation System (LAS) Areas of expertise include: Knowledge of cGMP and GLP, GLIMS, Non-Conformance software (DEV, CAPA) Experience in HPLC, UV, IR, TLC, KF, Dissolution |
Education
BS:Chemical EngineeringMapua Institute of Technology, City, PhilippinesChemical Engineering
Experience
Eurofins Scient.Tampa , FLStability and Regulatory Associate05/2015 to Current
- Review stability data to establish expiry term and labeling which includes trend evaluation and and statistical analysis.
- Author data summaries and assessments for stability portions of regulatory submissions.
- Represent Stability on multiple new product development project teams and provide guidance regarding stability regulations/ requirements.
- Provide formal responses and declaration to agency queries, Ensure that stability aspects of new products are assessed, reviewed and maintained throughout all development phases Design robust stability protocols to meet global requirements.
- This includes designing registration, In Use/PAO, Photostability, Bulk, and Freeze Thaw/High Temperature stability protocols.
- Authored Rx to OTC switch for respiratory product within time lines and no regulatory queries.
- Coordinated the destruction of samples as a result of facility relocations.
- Use LIMS to create and initiate stability testing protocols.
- Manage stability logistics with contractors globally (i.e.India)
- Investigate Out of Trend or Out of Specification stability results, determine root cause and implement Corrective and Preventative Actions (CAPAs).
Wacker Chemie AgAdrian , MISenior Scientist09/2013 to 03/2015
- Created and modify stability protocols in different stages (development, clinical and registration) Established and maintained study files of stability projects of different pharmaceutical companies Reviewed protocols and test data reports of stability studies.
- Reviewed environmental units charts and daily chamber checks Initiated and managed deviation cases using Trackwise/CAPA application Authored quality forms, such as in-coming sample log and sample destruction, to provide traceability and timely process of stability samples from protocol creation to study initiation.
- Revised departmental SOPs to reflect current practices and improve efficiency.
- Revisions indicated clearer directions on creating stability data and path to access.
- Implemented changes in departmental processes, such as use of quality forms in sample receiving, sample destruction and protocol requests improving workflow processes, resulting to better traceability and accurate documentation.
- Trained others on use of LIMS, revisions in SOPs and processes, which resulted to efficiency, better time management and compliance.
MallinckrodtPharmaceuticalsColumbia , SCSenior Scientist/ Stability Administrator06/2004 to 06/2013
- Responsible for the normal operation and proper maintenance of stability environmental chambers.
- Manage stability function activities for Pharmaceutical Analytical Development projects.
- Created, modified and approved stability protocols in different stages (development, clinical and registration) in Labware Established and maintained study files of stability projects in PHAD Reviewed and approved calibration certificates, revisions and change controls of equipment, qualification protocols and reports of environmental units and lab equipment.
- Managed deviation and change control cases using TQW and AQWA applications Introduced and implemented the use of 21 CFR Part 11 particle counting system Provided training on the operation of the HIAC particle count system Upgraded and expanded the Labwatch monitoring system for environmental chambers Created and validated performance qualification protocol on monitoring system.
- Authored and revised equipment SOP's.
- Provide support to Site Operations, Engineering and QA services to improve compliance.
Health Research, Inc.Nassau County , NYSenior Chemist01/2002 to 01/2004
- Supervised and managed Consumer Healthcare quality control laboratory; Products analyzed were mouthwash, body wash, body lotion and cream Conducted weekly review of SOPs with three direct reports to improve compliance Managed LIMS by updating specification dictionaries with current product specifications.
- Maintained stability protocols, study initiation and analytical testing of release and stability samples Reviewed and validated lab notebooks and LIMS entries for batch release and production Interfaced with R&D, Operations, Planning and Suppliers to facilitate release of raw materials and finished products Resolved stability and production OOS issues Assessed lab operation and test analysis and helped reduced cost of lab expenses by implementing changes such as use of equivalent non-USP standand for physical testing, minimized test and solvent solutions to reduce waste, incorporating wash cycles after LC runs, and other improvement.
BRISTOL-MYERS SQUIBB COCity , STATESr. Analytical Chemist01/1993 to 01/2001
- Responsibilities included testing of finished products, stability samples and radioactive drugs Calibrated lab equipment Conducted assays and uniformities of fills and stability batches using HPLC, UV and chemical methods of analysis Increase quality analysis of batches by amending SOPs based on test procedures Tested production and clinical batches for particulate matter using HIAC and membrane filtration.
- Trained R&D staff on HIAC particle counts procedure enabling establishment of new operations in Canada and US.
Raw Material Chemist01/1991 to 01/1993
- Analyzed raw materials using qualitative and quantitative tests methods.
- Recorded and Maintained lab data.
NACity , STATEAssistant Research Scientist01/1990 to 01/1991
Professional Training and Certification
Six Sigma Process Excellence
Stability Conference: Current Trends and Best Practices to Support Global Markets
Skills
21 CFR Part 11, calibration, charts, documentation, Documentum, forms, GLP, HPLC, notebooks, LIMS, Laboratory Information Management System, logistics, qualification protocol, processes, protocols, quality, QA, quality control, receiving, SOP, Specification, statistical analysis, time management, Trend, UV, reduce waste, workflow, Author
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Resume Overview
School Attended
- Mapua Institute of Technology
Job Titles Held:
- Stability and Regulatory Associate
- Senior Scientist
- Senior Scientist/ Stability Administrator
- Senior Chemist
- Sr. Analytical Chemist
- Raw Material Chemist
- Assistant Research Scientist
Degrees
- BS : Chemical Engineering
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