TERRA SMITH
Allendale,USA
Summary
Dynamic Quality Assurance professional with over 11 years of experience as a Senior Manager of Product Release Compliance in the pharmaceutical manufacturing sector, complemented by a Master of Science in Pharmaceutical Science: Quality Assurance and Regulatory Affairs. Offers a decade of laboratory expertise in pre-clinical Research and Development, supported by a Bachelor of Science in Animal Science and Conservation. Recognized for exceptional organizational skills and reliability while thriving in multi-disciplinary scientific environments, demonstrating the ability to excel both independently and as part of complex teams. Detail-oriented with a strong work ethic and a commitment to continuous learning, dedicated to providing essential support and leadership within the Quality field.
Overview
25
25
years of professional experience
1
1
Certification
Work History
Senior Manager, Product Release Compliance – Quality & Compliance
Eagle Pharmaceuticals, Inc.
01.2020 - Current
- Management/review/release of batch records for Eagle products in clinical development and commercial production.
- Compile Annual Product Quality Reviews.
- Quality Team Leader for multiple products.
- Communicate and work closely with CMOs in all areas.
- Responsible for assuring SOPs related to batch record review and release as well as Annual Product Quality Reviews are maintained and are up to date.
- Assist with other activities relevant to the Quality Department as needed (ex. FDA inspections, project team meetings, complaint processing, auditing, document tracking, data reviews, etc.)
- Manage and maintains databases to issue trends as needed.
- Utilizes and supplies administrative support for the electronic documentation system (SOLABS).
- Knowledge and understanding of GMPs, federal laws and regulations pertaining to the manufacture of sterile pharmaceuticals.
- Knowledge of the facility's equipment procedures and controls used in pharmaceutical production.
- Excellent communication and negotiation skills.
- Well organized and detail oriented.
Quality Specialist (Consultant) – Quality & Compliance
Eagle Pharmaceuticals, Inc.
10.2013 - 01.2020
- Review (and Release) Commercial, Clinical, and Registration manufacturing batch records.
- Review Process Validation Reports and Documentation for all products.
- Ensure compliance across lots (cGMP, 21 CFR 210 & 211, SOPs, Quality Agreements, etc.)
- Review deviations and investigations concerning all commercial products.
- Collect/compile batch data for trending and information purposes.
- Review/compile Annual Product Quality Reviews for all commercial products.
- Assist in all Regulatory Agency visits, internal audits, etc. at Eagle site.
- Work closely with supply chain in disposition and shipping of commercial product to the market.
- Work closely with Regulatory to aid in Annual Product Submissions and other regulatory filings.
- Represent QA for any necessary CMO visits, etc.
- Attend/participate in product team meetings, supply chain meetings, conference calls, etc.
- Effectively communicate both verbally and in writing to CMOs, product teams, etc.
- Provide training to necessary personnel for batch record review/release process.
- Create and maintain associated QA SOPs.
- Proficient in Solabs (Electronic Document System).
- Compile and enter all Field Alerts, HRA, and other Quality Documents into Solabs.
- Proficient in Word, Excel, PowerPoint, Microsoft Office/Outlook.
Associate – In Vivo Research Group within Comparative Animal Research (Fixed Term Contract)
Amgen Inc.
10.2010 - 05.2011
- Assist with all in-life, and post in-life study activities.
- Proficient in rodent dose administration (PO,IV,SC,IM,IP), sample collection techniques, prosection, and all necropsy duties, operation of lab equipment, effective documentation procedures.
- Compiling and communicating data to investigators, maintain study computer files, meet timelines.
- Proficient in MS Word, Outlook, PowerPoint, and Excel
- Proficient in Xybion data collection system
- Attend and Contribute in both group site and cross-site meetings
- Effective communication, interpersonal and organizational skills.
Scientist – Pre-Clinical Safety Assessment, Toxicology
GlaxoSmithKline Pharmaceuticals
11.2003 - 06.2009
- Prepare, manage, and perform in-vivo toxicology studies on rodents, canines, and non-human primates.
- Experience in all procedural aspects of in vivo toxicology studies involving rats, mice, canines, and NHPs within both GLP and non-GLP environments.
- Conduct both GLP and non-GLP laboratory procedures using the standards set forth in both worldwide regulatory guidance documents and GSK SOPs and Protocols.
- Work independently and within a complex study team to effectively carry out laboratory study procedures and tests.
- Generate data; communicate observations and present data, in both oral and written forms to co-workers and management.
- Proficient in all aspects of in vivo animal handling, restraint, and administration of anesthesia, euthanasia, and dosing (Oral, SC, IP, IM, IV) of rodents, canines, and NHPs.
- Perform necropsy, identify macroscopic observations, and preserve tissues for rodents, canines, and NHPs.
- Collect urine and take blood samples for Clinical Pathology as well as DMPK parameters - via femoral, tail, jugular, and/or cephalic veins for all species.
- Conduct electrocardiograms on canines and NHPs utilizing the EasyECG Computer System for data collection.
- Proficient in recording in-life study observations within regulated computer data collection systems.
- Establish and maintain raw data study notebooks, as well as evaluate and audit study notebooks/reports.
- Train new employees in technical skills such as bleeding, dosing, tissue collection, and study management.
- Formulate vehicles for dosing via multiple routes of administration for drug dispensary.
- Perform animal macro-photography by selecting appropriate camera settings using digital SLR Cameras to capture images of gross specimens at necropsy.
- Participate in laboratory safety inspections, and act as a representative on the site Safety Committee.
- Oversee GLP freezers for sample storage/distribution and facilitate maintenance per SOPs.
Senior Laboratory Technician
GlaxoSmithKline Pharmaceuticals
05.2000 - 11.2003
- Utilize animal handling and restraint.
- Review, learn, and follow all departmental protocols, GLPs and SOPs.
- Give study support by performing rodent dosing, blood collection, urine collection, and euthanasia.
- Make daily observations related to the condition and health of animals.
- Perform animal husbandry and maintain technology and facilities in a hospital-clean state of sanitation.
Education
M.S. - Regulatory Affairs & Quality Assurance
Temple University: School of Pharmacy
Fort Washington, PA01.2010
B.S. - Animal Science & Conservation
Delaware Valley College
Doylestown, PA05.2000
Skills
- Strategic planning
- Cross-functional collaboration
- Operations management
- Cross-functional team coordination
Certification
Certificate of Drug Development - Temple University 2009
Timeline
Senior Manager, Product Release Compliance – Quality & Compliance
Eagle Pharmaceuticals, Inc.
01.2020 - Current
Quality Specialist (Consultant) – Quality & Compliance
Eagle Pharmaceuticals, Inc.
10.2013 - 01.2020
Associate – In Vivo Research Group within Comparative Animal Research (Fixed Term Contract)
Amgen Inc.
10.2010 - 05.2011
Scientist – Pre-Clinical Safety Assessment, Toxicology
GlaxoSmithKline Pharmaceuticals
11.2003 - 06.2009
Senior Laboratory Technician
GlaxoSmithKline Pharmaceuticals
05.2000 - 11.2003
B.S. - Animal Science & Conservation
Delaware Valley College
M.S. - Regulatory Affairs & Quality Assurance
Temple University: School of Pharmacy
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