Management Quality

JOSEPH (JOEY) L. RASKA

**** ******** **** 919-***-**** (c)

Durham, NC 27712 https://www.linkedin.com/in/joeraska15 **********@*****.***

QUALITY SYSTEMS AND COMPLIANCE MANAGEMENT

Degreed professional with progressive career successes in quality processes and operations (validation audit, RCA, CAPA, QMS, Risk Management and training), project management, and business development

An individual who is recognized for achieving performance at unprecedented levels through hands on leadership, accountability, and creating motion and momentum among team members

Thrives on challenging opportunities and taking ownership to resolve problems within fast paced work environments

17+ years pharmaceutical GxP experience (pre-clinical, clinical, and post approval) with strong working knowledge of pertinent regulations from various agencies such as FDA, EMA, ICH, ANVISA, WHO etc

Product lifecycle development and management including contributing to CMC regulatory submissions for large and small molecules across multiple dosage forms (solids, inhaled, biologicals, sterile injectables and topicals) and working knowledge of medical device quality systems regulations

NOTABLE ACCOMPLISHMENTS

Developed and implemented internal and self improvement audit programs for several cross functional team such as laboratories, safety, Procurement and QA

Harmonized and simplified quality documentation (e.g. SOPs annual product reviews and work instructions) to increase compliance from end users, and ensure strategic alignment

Applicaton of drug product development knowledge coupled with all business aspects of the processes (analytical, Procurement, budgets, quality, supplier management, quality agreements, safety etc.) allow me to engage at multiple key steps of regulatory activities

Developed and implemented new functional quality team at Tergus Pharma, Quality Shared Services

EXPERIENCE

Tergus Pharma 2015 – 2016

Manager, Quality Shared Services

Key Quality interface for QC labs and QA

Deviation, CAPA and change control lead for functional Quality

Manage and lead self improvement and external audit programs

Chose and implemented LIMS system (SLIM) and other sofware

Higher, manage, develop staff and support training programs for new staff

Create, develop and improvement of SOPs as part of company’s QMS

General systems and process improvements through kaizen and process mapping and gap analysis

Manage validation execution and implementation for IT and equipment projects

Metrology management for facilities and laboratories

Manage, train and lead staff across formulation, early development, IVRT (In-Vitro Release Testing) and QC teams

Safety and Chemical Hygiene Officer

Stability process improvements and management

Manage consultant and vendor interface to leverage spend

GlaxoSmithKline (Stiefel) 1999 – 2015

Manager, Business Operations and Technical Services (2013 – 2015)

Created and managed Global matrix teams/staff in support of quality and compliance programs for internal audits, risk management (FMEA), change control and CAPA management, reducing critical and major audit findings to 0%

Provided input and review for internal/external audits and quality agreements aligning strategies with corporate Regulatory Affairs and external Regulatory inspectors

JOSEPH (JOEY) L. RASKA – **********@*****.*** PAGE TWO

Managed internal EHS audits and reported issues to management teams

Authored, maintained and reviewed GMP documentation

GMP Curricula Training Coordinator and Trainer

Managed clinical supply and labeling processes

Managed reporting of metrics to, and influence of leadership for critical quality programs

Created and managed Global outsourcing procedures (RFI/P/Qs and contracts), leveraging supply base to reduce costs by >10%

Leader, Quality Lab Applications and Stability Services (2011 – 2013)

Developed and implemented self-improvement/EHS audits and risk management programs

Provided backroom audit support during external Regulatory audits by various agencies such as US FDA, Saudi FDA and COFEPRIS

Managed change control while creating and delivering processes for system audits, quality councils, risk management and CAPAs

Global QMS content owner for QMS documents including but not limited to global stability testing, quality management plan, risk management, auditing and shipping

Led simplification and reduction of SOPs by 50%, while maintaining quality and regulatory expectations of the QMS

Business Process and Change Management Stability Lead for implementation of LIMS to GMS globally, IT validation and quality IT approver

Reported progress and metrics to leadership, tracking adherence to QMS and LIMS delivery

Leader, Stability Standards (2007 – 2011)

Devloped and implemented ‘Stability Kaizen’ for sites to review and streamline stability programmes based on current and changing regulatory expectations such as AVNISA

Accountable for leading/aligning audits, stability standards and practices across more than 70 sites in the GMS network

Hosted total disclosure internal audits for new SSS

Provided backroom audit support during external Regulatory audits by various agencies such as US FDA, Saudi FDA, Swiss Medic and COFEPRIS

Managed change control for creating and delivering processes to include quality council, risk management and CAPAs

Authored, maintained and reviewed GMP documentation and led associated training

GMP Curricula Training Coordinator

Review and input to APQRs

Procurement Sourcing Manager (2005 – 2007)

Performed GMP and technical audits of internal labs and third party vendors

Collected metrics to ensure quality, compliance and assurance of supply from preferred vendors, and maintaining financials for outsourced work

Supplier relationship management

Created and managed contracts for R&D Procurement

Managed supplier database and spend >$3 million while meeting targets of saving $1 million in negotiated clinical and non-clinical contracts

Team Manager/Senior Scientist (1999 – 2005)

Guest auditor for supplier quality audits

Addresssed questions during external Regulatory audits for various agencies such as US FDA, SwissMedic, Saudi FDA and COFEPRIS

Team Leader and analyst for cascade impaction, impurities, content/dosing uniformity and physical testing teams on inhaled and solid oral dosage forms

Authored relevant sections of regulatory submissions

Data reviewer/approver

Drug development and validation for Phase I-IV studies (analytical and clinical)

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Implemented a stability tracking program to manage resources and redce testing cycle times by 15% year/year annually

Review and input to APQRs

Supplier relationship management

Managed suppliers, sourcing contracts and spend >$3 million and reduction of cost by >15%

Magellan Laboratories 1998 – 1999

Analytical Chemist

Envirolab 1996 – 1998

Senior HPLC Analytical Chemist

Karr Environmental 1994 – 1996

Senior Analytical Chemist

EDUCATION AND TRAINING

Bachelor of Science, Chemistry, Stetson University, DeLand FL

Greenbelt Certification in Lean and Six Sigma

RCA trained facilitator

First line Leader

Additional training hours in GCP (5+ ACRP), Management (5+) and Auditing (5+)

AWARDS

One PRO and Eight ERAs at GSK

AFFILIATIONS

NCCSQA and ASQ

Boy Scouts of America Assistant Scout Master and STEM Counselor

OTHER SKILLS

Expertise in computer skills: Microsoft Excel, Word, PowerPoint, Visio and Project, Lotus Notes, Outlook, TrackWise, LIMS, LIFT, MERP

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