Quality Assurance Professional Experience
Resume:
Phoenixville, PA *****
J. Jay Oustrich
Home Phone: 610-***-****
Email: ********@*******.***
Objective:
To secure a position that allows me to manage the logistics and quality assurance of a growing and dynamic firm.
Career Profile:
Exceptional analytical skills and ability to focus skills toward solution-driven results
Skilled in following, auditing, and authoring SOP’s as well as User Manuals
Knowledgeable in Good Distribution Practices as well as practices documented in 21 CFR parts 210-211
Skilled in utilizing SAP, TrackWise, GDRS, and Microsoft Office applications
11 years’ experience in the logistics and quality assurance of a CRO and pharmaceutical firm
2 years’ experience in the logistics of a major pharmaceutical firm
Professional Experience:
CSL Behring King of Prussia, PA
Logistics Quality Specialist- Logistics Americas (Contractor) 09/2015 - present
Supported the Logistics QM Team to ensure all ongoing KOP Logistics quality systems and transactions are compliant to CSL and federal regulatory requirements.
Review all inbound and export transport temperature data and product batch status with SAP as per established CSL procedures.
Initiated and monitored all temperature excursion/deviations utilizing TrackWise software.
oManaged weekly meetings with all associated internal and external stakeholders and assured all corrective/preventative actions as well as any assessments are completed in a timely fashion.
Supported the Logistics Quality Delegate to:
oManaged the 3PL quality relationship regarding the management of non-conformance events during receipt, handling, storage and distribution of CSL products.
oTracked errors, shipping complaints due quality issues, taking actions when negative trends are noted; following up on corrective and preventative actions to assure trends are reversed.
oResponded to inquiries with CSL and the 3PL regarding status and location of batches being transported, including quality release statuses.
oPeer-reviewed and approved Change Controls, Deviations, and SOPs.
Supported the Logistics Validation Scientist in the preparation and coordination of the development of the qualification and validation protocols for cold chain shipping containers, cold chain transports, and cold chain distribution channels through to CSL customers ready for final approval.
Supported the management, approval, and storage of qualified documents utilizing the GDRS system.
Supported the Regulatory Affairs department in the generating and review of Lot Distribution Data reports in preparation of bi-annual FDA submissions.
Authored and updated SOPs, User Manuals, and other training materials.
PPD - Vaccines and Biologics [Pharmaceutical Product Development] Wayne, PA
Shipping/Biorepository Supervisor 02/2007 – 10/2014
Developed new procedures, authored the associated SOPs, and maintained departmental compliance in response to the change in employer’s new policies toward biorepository quality assurance and GLP and cGMP processes.
oManaged the maintenance of various controlled temperature units (i.e. Freezers, cold rooms, N2 dry cabinets, cryogenic units) utilizing the GEKaye Labwatch Biorepository Monitoring System
Monitored the temperature trends on a re-occurring basis to ensure acceptable temperature compliance
Conducted the following cyclical checks
Maintenance checks to ensure timely repair, preventative maintenance, and calibration
Safety checks to ensure units are compliant with OSHA standards
Compliance checks to ensure standard operating procedures and validation are upheld
oCollaborated with facilities and quality assurance departments to confirm full resolution of all non-compliance and repair issues
oResponded to after-hour biorepository emergencies and ensured clinical sample integrity
oLed presentations for client process/facility audits, rectified any outstanding issues
Developed new procedures, authored the associated SOPs, and maintained departmental compliance in response to the change in employer’s new policies toward the logistics of incoming and outgoing shipments
oProcessed incoming shipments from each of the clients’ specific and proprietary clinical trials supply management database
Maintained a proper chain of custody as clinical trial samples are transferred to testing or biorepository storage
Collaborated with downstream stakeholders to ensure proper transfer of shipments and supplies
Inspected incoming packaging, and maintained proper documentation and resolved of any shipping/packaging discrepancies upon arrival
oProcessed outgoing shipments (domestic and international)
Ensured all packaging is DOT/IATA compliant
Authored monthly shipping cost reports, negotiated shipping rates with logistics carriers
Key Accomplishments:
Developed and authored several of the safety procedures associated with Dock/Biorepository area
Provided logistics support in in the International Society for Biological and Environmental Repository’s (ISBER) study 2012 best practices for repositories collection, storage, retrieval, and distribution of biological materials for research international society for biological and environmental repositories.
Provided solutions and followed through after company-wide ergonomic audit.
Hydrocarbon Publishing, Inc. Frazer, PA 04/2006– 02/2007
Technical Writer
Researched various sources on the latest technologies of the petroleum refining industry
Authored various articles on the petroleum refining industry for a monthly periodical
Education:
Bachelor of Science in Physics, Virginia Tech University, Blacksburg, VA [1990]
Graduate Certificate in Secondary Education, West Chester University, West Chester, PA [1996]
Skills & Tools:
MS Office 2010, GEKaye Labwatch Monitoring System, Proprietary Clinical Supply Management Database, SAP, TrackWise, GDRS
Certifications:
DOT/IATA Certification for Shipping and Handling Dangerous Goods
EPA/DOT Certification for Hazardous Waste Handling
Other Interests:
Member-at-Large: St. Basil Parish CYO Board
Track & Field Coach and Cross-Country: St. Basil and Holy Family CYO
References:
Mr. Edward Kaercher (Relationship: Former Director) Ms. Annalise Simonson (Relationship: Colleague)
Director of Facilities and Engineering Logistics Validation Scientist
PPD Vaccines and Biologics CSL Behring
******.********@****.*** ********.********@**********.***
Mr. Daniel Sweed (Relationship: Former Manager) Mr. Andrew Robinson (Relationship: Director)
Head, Logistics Quality Americas Director Global Logistics Quality Management
CSL Behring CSL Behring
******.*****@**********.*** ******.********@**********.***
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