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.

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.

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.

• 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.

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.

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.

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.

Business Admin

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