Heather Hoffman Email & Phone Number

Accupac LLC 2010 - Present Quality Assurance Document Coordinator • Create GMP controlled documents for Over the Counter and Personal Health Care Products• Completes special projects as required by management while meeting deadlines. • Assist in the creation, editing and circulation of Standard Operating Procedures. • Work with little supervision in a team environment recording Material Assay Reports for annual product reviews for Customers.• Assist Vice President of Quality Assurance in daily activities as they relate to company activities and audits including document scanning and distribution of data to the Customers. • Manage file systems for customer product specification. • Responsible for production controlled batch records and their file maintenance.• Maintain department supplies.

Create GMP controlled documents for Over the Counter and Personal Health Care ProductsCompletes special projects as required by management while meeting deadlines. Assist in the creation, editing and circulation of Standard Operating Procedures. Work with little supervision in a team environment recording Material Assay Reports for annual product reviews for Customers.Assist Vice President of Quality Assurance in daily activities as they relate to company activities and audits including document scanning and distribution of data to the Customers. Manage file systems for customer product specification. Responsible for production controlled batch records and their file maintenance.Maintain department supplies. Icon Clinical Research Inc. 2009Document Management File Coordinator File Coordination maintaining Clinical Study files for Major Pharmaceutical Customers Maintain supplies for scanners and file maintenance. Proven ability to multi task projects while maintaining time lines for delivery of projects

Maintain calendars and meeting schedules for on time results for Executive Director and two Associate Directors, including, Video & Tele conferences using company software.Professionally greets and assists Global clients, visiting professors and vendors for the group.Managing information in eRooms for meetings and developing agendas associated with Bioprocess. Schedule travel for domestic and International business needs while completing expense reports associated with travel and department expenses.Completes special projects as required by group while meeting deadlines and replenishing department supplies and catering needs. Implement successful transition for new hires orientation into the group using e-move desk software. Familiar with scanning documents and use of various copiers and fax machines for document appropriation. Sort and deliver mail and order supplies for group needs.

JOHNSON & JOHNSON 1992 – 2007PHARMACEUTICAL RESEARCH & DEVELOPMENT, Spring House, PAAdministrative Assistant & Senior Lab Coordinator in Bioanalytical group 2004 – 2007• Maintained calendars and meeting schedules for the East Coast Global Director.• Supported all Bioanalytical group activities by regularly scheduling meetings and needed resources. • Asked to maintain confidentiality with accurate department information dissemination.With study teams and other document management staff to fulfill job responsibilities• Selected by management to coordinate activities with Human Resources and recruiting agencies regarding candidates’ resumes and interview schedules. Implement successful transition for new hires. • Regulatory support as needed: correspondence, file maintenance, data entry.• Developed file systems for clinical and analytical data results, clinical investigational studies file, sample tracking records, protocols and investigational data.• Professionally greeted all levels of management, business clients and candidates and assisted their schedule requests with professional confidence. • Scheduled appointments, internal and external meetings, lodging, transportation and refreshments for clients and consultants. Promptly resolved any problems to arise by knowledge of facilities and available vendors. • Implement successful transition for new hires orientation into the group using e-move desk software.• Maintained successful DOT & IATA certification and subsequent re-certifications to perform the duties and associated regulations (IATA and 49 CFR).

2007Maintained calendars and meeting schedules for the East Coast Global Director.Supported all Bioanalytical group activities by regularly scheduling meetings and needed resources. Asked to maintain confidentiality with accurate department information dissemination.With study teams and other document management staff to fulfill job responsibilitiesSelected by management to coordinate activities with Human Resources and recruiting agencies regarding candidates' resumes and interview schedules. Implement successful transition for new hires. Regulatory support as needed: correspondence, file maintenance, data entry.*Developed file systems for clinical and analytical data results, clinical investigational studies file, sample tracking records, protocols and investigational data.Professionally greeted all levels of management, business clients and candidates and assisted their schedule requests with professional confidence. Scheduled appointments, internal and external meetings, lodging, transportation and refreshments for clients and consultants. Promptly resolved any problems to arise by knowledge of facilities and available vendors. Implement successful transition for new hires orientation into the group using e-move desk software.Maintained successful DOT & IATA certification and subsequent re-certifications to perform the duties and associated regulations (IATA and 49 CFR).*

Organized and maintained clinical study confidential files and information. Shipped documentation, analytical reference compounds, study samples and clinical supplies for Bioanalytical group studies placed in-house as well as contracted studies to consistently meet time lines.Tracked clinical and pre-clinical study samples in electronic file system, Watson Laboratory Information Management System (LIMS) with quality results.Front line contact with carriers, forwarders, and brokers to schedule outbound order traffic.*Researched requested study specific supplies for clinics and analytical laboratories so that data delivery has on time results. Communicated with contract research organizations and analytical facilities, Carriers and Customs Brokers, responding to questions concerning scheduling sample deliveries and supply requests in a GLP Good Laboratory Practice environment.Maintain files with protocol updates and revisions as well as provide scanning of documents for team. Filing (electronic and physical).Maintained successful DOT & IATA certification and subsequent re-certifications to perform the duties and associated regulations (IATA and 49 CFR).* Maintain an efficient system of traceable regulated investigational compounds to be audited by FDA.

Received clinical study material, samples and data, providing same day results to department scientists.Received and tracked all investigational compounds and kept continued log books for audit accountability.Maintained file storage and inventory in a GLP environment, audited by Quality Assurance group with continued positive outcome on audit reports.Continued to achieve an up-to-date training program for department qualification. Maintained successful DOT & IATA certification and subsequent re-certifications to perform the duties and associated regulations (IATA and 49 CFR).* Supplied all contracted research organizations with investigational compounds, implementing accountability by documentation to ensure tracking from site to site.

Business Admin

Education record