Denise Anne Waltz

*** ******** ***

Miller Place, NY 11764

Home Phone 631-***-****

OBJECTIVE: To continue to grow and expand my role in Quality Assurance Documentation by seeking increasingly challenging responsibilities.

Professional Experience:

Kedrion Biopharma, Melville, NY

July 2013 present Quality Associate II

Cumulative Responsibilities Include:

Supervising and scheduling of documentation staff

Coordination with Quality Control to ensure product release timelines are met

Generation of product certifications

Product release utilizing paper based and SAP systems

Management of Change Control Program

Generation and review of Manufacturing Batch Records

Management of Standard Operating Procedures program

Ensuring compliance to cGMPs

Grifols Biotherapeutics, Melville, NY

July 2011 June 2013 Quality Associate II

Cumulative Responsibilities Include:

Supervising documentation staff

Generation and review of Manufacturing Batch Records

Management of Standard Operating Procedures program

Generating, reviewing, and issuing all Manufacturing Batch Records and Log Books

and subsequent record reproduction

Assisting in Documentation Library organization and streamlining procedures

Coordinating Change Control Program

Ensuring compliance to cGMPs

Talecris Biotherapeutics, Melville, NY

August 2009 – July 2011 Quality Associate

June 2005 August 2009 Quality Assurance Specialist

Cumulative Responsibilities Include:

Supervising documentation staff including daily scheduling and project assignment

Maintaining and controlling donor database, including donor availability verification, test result review, and release of units to production

Oversight of Standard Operating Procedure program

Review and approval of Manufacturing Batch Records and Log Books

Assisting with QA aspects of Change Control program

Precision Pharma Services, Melville, NY

April 2003 June2005 Quality Assurance Specialist

May 2001-April 2003 Quality Assurance Documentation Coordinator

Cumulative Responsibilities Include:

Supervising and administering Pilgrim Documentation Management System, including database troubleshooting, compliance assessments, and validation

Maintaining and controlling Standard Operating Procedure database, including status checks, revision histories, and review tracking

Preparing and reviewing lookback destruction paperwork (Medical Waste Management)

Reviewing and issuing all Standard Operating Procedures

Generating, reviewing, and issuing all Manufacturing Batch Records and Log Books

Performing annual SOP review

Generating electronic manufacturing records and subsequent record reproduction

Assisting in Documentation Library organization and streamlining procedures

Ensuring compliance to cGMPs

VITEX, Melville, NY

June 1999- April 2001 Primary Receptionist / Administrative Assistant

Responsibilities Include:

Primary receptionist for 175-employee facility, directing telephone inquiries, and responsible for signing staff and guests in/out of the facility. Dealing with potential customers.

Assisting Building Service mechanics with the Building Alarm System by receiving, tracking status, and closure of alarm conditions

Administrating the orientation of new employees, along with assigning ID with the Computerized Badge System.

Coordinating the time sheets of the building service mechanics.

Additional Skills:

Extensive computer skills with proficiency in Word, Excel and database management

Strong interpersonal skills developed through years of professional interactions

Independent worker with proven success in multiple project arenas

EDUCATION

Johnson & Wales University Providence, R.I.

1996-1997 Studied Management with emphasis in Marketing.

Recipient of DECA Academic Scholarship.

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