Donna Slaff

*** **** ******* ****, ********* Pa., 17601

Phone: 732-***-****, acshbk@r.postjobfree.com

QUALIFICATIONS PROFILE

Experience in the Pharmaceutical Industry; Procedural Documentation, Training, E-Learning, Driving Compliance and Kepner - Tregoe certified Qualified Investigator.

Able to lead cross functional Subject Matter Resources (SMRs) to create and revise departmental procedural documents (SOPs/WIs) to align with governing documents, incorporating deviations and CAPAs

Experienced in procedural document enhancements such as Job Aids, Cleaning Log sheets, and Hands on Evaluation Checklist to assure compliance and assess performance.

Able to determine training audience and recommend the appropriate training.

Experienced in developing training programs to enhance procedural document comprehension along with regulatory guidelines to fulfill professional development needs.

Experienced in developing and maintaining Role Based Curriculums for specific job functions

Developed and implemented a wide variety of on-line training and knowledge checks utilizing Power Point, Plateau, Question Mark, SharePoint, and Adobe Connect.

Proven ability to drive compliance

Able to effectively and efficiently investigate Quality Events in a consistent manner while assuring compliance with procedures and quality systems utilizing Trackwise.

Strong Leadership, excellent organizational and communication skills.

PROFESSIONAL EXPERIENCE

Protocol for International Paper, Thorofare, New Jersey, July 2015 – Present

Training Specialist

Performed a gap analysis of a non GMP manufacturing facility and identified GMP deficiencies.

Work closely with Functional Area Management (FAM) and Subject Matter Experts (SMEs) to create Standard Operating Procedures (SOP) and Work Instructions (WI).

Work closely with supervisors and management to identify training opportunities for new and or revised processes.

Created a Training Database (to capture all Thorofare and Clifton employee performing GxP activities including but not limited to reporting structure, employee’s roles and responsibilities, training items (when assigned, when completed, assessment type) curriculums (items found in each curriculum) and qualified trainers) for all roles as defined in governing documents.

Collaborate with FAM and SMEs to develop Role Based competencies.

Review training materials for accuracy and validity and provide feedback to Doc Authors and Process Owners.

Develop and Design Training Material, power point presentations, knowledge assessments, evaluation checklists.

Communicate when procedures are approved and pending training to target audience.

Send employees deficient in training friendly reminders and weekly training metrics to department management.

Deliver Training; i.e. New Hire On-Boarding, GMP, Employee Responsibility, Inspection Readiness, and Good Documentation.

Validant for McNeil, Lancaster, Pennsylvania. November 2012 – December 2014

Consent Decree Consultant - Training Specialist

Collaborate with Document Authors, Functional Area Managers (FAM) and Subject Matter Experts (SMEs) to ensure Standard Operating Procedures (SOP) / Work Instructions (WI) accurately reflect activities performed.

Responsible for developing training for Standard Operating Procedures (SOP) / Work Instructions (WI) and processes to support operations.

Run and monitor curriculum and item reports to ensure the necessary employees have been assigned and qualified to perform their assigned tasks.

Analyze, design, develop, implement, and evaluate (ADDIE) instructor-led courses and e-learning modules and develop criteria to evaluate and qualify employee to perform their tasks as defined in their job description and maintain the training and development library

Collaborate with Qualified Trainers, Subject Matter Experts, and Functional Area Management to determine target learning levels (awareness, comprehension, and application), target audience, (as per their roles and responsibilities) learning objectives, delivery methods, and training materials.

Deliver Training i.e.,GMP New Hire Orientation, Train-the-Trainer Programs (both Instructor Led and On the Job Training) Employee Responsibility, Inspection Readiness, Compliance Wire and other courses owned by the Training Department.

Germer International for CorePharma, Middlesex, New Jersey. June 2012 – October 2012

Senior Manager Training

Determine training needs in collaboration with various department heads.

Develop training matrices to define the training requirements for each job description.

Develop training modules with internal and external subject matter experts

Create and maintain training content, lesson plans and knowledge transfer assessments for specific technical skills and cGMP training topics.

Develop systems and procedures for documenting training program to ensure the systems and procedures are maintained in a current compliant state.

Interface with regulatory agencies regarding training policies, procedures and documentation.

InVentiv Health Clinical for Daiichi Sankyo, Edison, New Jersey June 2011 – June 2012

Manager, Training & Procedures - Consultant

Manage and maintain the GXP Training Program for DSPD, DSI, DSD and DSID locations to assure regulatory compliance and the documented required knowledge level for each employee and contractors within this scope.

Participate as a Functional Subject Matter Expert in the implementation of the electronic Learning Management System (Plateau) to support a robust, regulatory compliant GXP training system business solution for use by DSI, DSPD, DSD and DSID personnel, with potential for expansion to other global sites.

Present training sessions, as needed, including the Quality Assurance Induction training to new hires.

Manage and maintain the review, approval and publishing process for GXP procedures, with participation in the SOP committee meetings, as necessary, to ensure the timely review and approval of procedures to ensure regulatory and business-critical processes are captured for consistent application. Participate as a functional subject matter expert in the upgrade of the RIMS system.

Participate during regulatory inspections (e.g. FDA, MHRA), audits by partner companies, and internal system audits, as needed, to assure that our training function and records, and our GXP procedural documents, are represented fairly and accurately and are current and available for review.

Bristol Myers Squibb, New Brunswick, New Jersey September 2005 – March 2011

Procedural Document Champion / Training Specialist

Facilitate teams of SMEs and department representatives to create new and or revise existing procedures to align with governing documents.

Scheduled kick off meetings with SMRs, create agendas, and questionnaires to determine training audience and type of training required.

Upload new and revised documents in SharePoint for collaboration, address comments and issues, and incorporate deviations and CAPAs.

Upload and circulate final draft procedures in Documentum for electronic review and approval.

Create required training (knowledge checks, quizzes, hands on evaluation checklist, job aids, cleaning log sheets etc.) utilizing power point presentations, Adobe Connect, Plateau and QuestionMark.

Create Role Based Curriculums (adding the necessary training items) and assign training audience to the appropriate curriculums based on their roles and responsibilities and monitor training compliance and training effectiveness utilizing EPIC, Crystal Reports.

Lead PRD compliance with procedures (policies, SOPs, WIs etc.) and regulations (GMP, DEA, OSHA, etc) by managing training requirements, qualification standards, and monitoring activities.

Manage PRD's Procedural Documents and ensure that they are appropriately indexed and periodically reviewed.

Manage and support Process R&D business systems for training, document management and document retention schedules.

Manage Centric Project to create BMS external user accounts, create new project workspace, and groups.

Qualified Investigator - Kepner-Tregoe (KT), Attend situation appraisal meetings and investigate quality events, Enter investigation in Trackwise, stay current with focus sessions.

Communicate ideas by working with others to accomplish goals and objectives, Adapt to ever changing business environments and position responsibilities, Learn new systems and processes and train others on how to use them.

Schering-Plough Research Institute, Kenilworth, New Jersey June 2001 – September 2005

GLP Compliance Specialist

Administrator for COMMANDR (Compliance Management Document Repository) SOPs

Support Lead System Analyst, Global Strategic Sourcing and Research Information System.

Run validation test scripts to assure operation/performance qualification

Format, Categorize and Maintain SOPs

Assist Departmental staff with SOP initiation, revision and review process

Liaison to QA and Laboratory staff scientists

Administrator for ECMS (Environmental Chamber Monitoring System)

Maintain equipment call list for refrigerators, freezers, environmental rooms and incubators found in ECMS and maintaining equipment set temperatures

Generate and provide temperature trends and reports when requested

Administrator for ProCal - CCMS (Computerized Calibration Management System)

Track and monitor Routine and Non-Routine Maintenance and calibration documentation for weights, balances, refrigerators, freezers, environmental rooms and incubators

Provide calibration records when requested

Compliance Issues

Audit Employee Training Binders, and Equipment Log Notebooks

Ensure routine calibration, maintenance and documentation for environmental monitoring system and weights and balances

Archive data records.

Block Drug Company, Jersey City New Jersey September 1996 - 2001

R&D Analytical Documentation Coordinator, 1999 - 2001

Responsible for the documentation and issuance of all Analytical R&D related documents.

Issue reports summarizing changes and new additions to USP/NF, PF, EP, BP, JP and FCC Supplements for R&D management.

Update all domestic and international raw material specifications and analytical test methods to assure compliance with designated monographs.

Maintain the Approved Vendors List for Corporate Quality.

Maintain the Analytical Validation Report database.

Generate new product specifications to conform with developmental and monograph requirements.

Stability Document Coordinator April 1996 - 1999

Create stability protocols and databases for the Technical Services Department.

Provide support to R&D Development groups, Regulatory Affairs and Corporate Quality in all stability matters, Generated annual stability reports for OTC Drug Products.

Review incoming data for accuracy and completeness.

Maintained both computerized and hard copy stability data repositories.

Analyze stability data in support of Expiration Date/Shelf Life Assignments.

Investigate stability failures, report findings and advised on corrective actions.

Carter Wallace, Cranbury, New Jersey 1993 - 1995

Analytical Chemist

Analyze, develop, and validate HPLC methods to test pharmaceutical drug products.

Operate and maintain the HPLCs and ancillary equipment, maintaining proper logs and documentation in strict compliance with FDA, GLPs and writing technical reports.

Support safety and environmental department with necessary data to determine the exposure of active drug release during production.

Perform cleaning evaluation on equipment for drug substance and residual detergents.

Support USP in their collaborative round-robin study to test new lots of dissolution calibration tablets to establish new acceptance ranges for prednisone and salicylic acid.

Document and calibrate for all pharmaceutical lab instruments and equipment (i.e. pipettes, Dissolution, Hardness, Friability, thermometer, baths, incubators, pH, UV, pumps, injectors, etc.) and re-certify in house standards.

Perform GMP review of laboratory data with respect to the stability batch records.

Wyeth-Ayerst Research, Monmouth Junction, New Jersey 1993 - 1993

Analytical Chemist Consultant

Develop and validate analytical procedures to measure the concentrations of drugs in New Drug Applications (NDA), and biological fluids.

Assess Metabolic Disposition.

American Cyanamid, Princeton, New Jersey 1992 - 1993

Analytical Chemist Consultant

Perform complex HPLC analyses for over the counter and pharmaceuticals to support drug product and stability studies.

Colgate-Palmolive, Piscataway, New Jersey 1991 -1992

Senior Laboratory Technician Consultant

Separate, isolate and characterize polymer additives in Colgate and competitor products utilizing size exclusion chromatography.

PACO LABS, Lakewood, New Jersey 1991 - 1991

Junior Chemist

Analyze all incoming raw materials prior to use in production, finished product prior to packaging and stability samples for cosmetic and pharmaceuticals using wet chemistry, HPLC, IR, TLC and UV.

Clark Colors, South Plainfield, New Jersey 1979 - 1984

Chemist

Develop, test and analyze Foods Drugs and Cosmetics (FD&C) colors.

EDUCATION:

William Paterson University, Wayne, New Jersey 1975-1979

BA, Biology/Minor Chemistry

PROFESSIONAL MEMBERSHIPS:

Association for GXP Excellence (AGXPE) - (2015)

GMP TEA (2010 – present)

ASTD Membership (2010-2011)

Question Mark (2005 – 2011)

WIST November (2005 – 2011)

ASTD Membership (2010-2011)

MARSQA Mid-Atlantic Region Society of Quality Assurance(2001 – 2006)

Society of Quality Assurance (2002 – 2006)

American Association of Pharmaceutical Scientist (1996 – 2001)

American Chemical Society (1993 – 1995)

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