Cynthia Whyte Email & Phone Number

Raritan, N. J.

- Support for product-related projects and investigations- Lead process and facility improvements in support of the manufacturing process- Perform root cause analysis assuring continuous improvement of OCD products and processes- Management of change control process- Perform quality oversight and approval of plant nonconformances- Provide support and subject matter expertise for regulatory audits- Provide quality over site of the biologics sterile fill operationOrtho Clinical Diagnostics is a leading global provider of in vitro diagnostics with an established track record for providing high-quality products and services to the global clinical laboratory and immunohematology communities.

Morristown, New Jersey

• Management of Equipment Qualification and Process Validation Projects • Management of consultant personnel• Management of costs associated with validation work contracted to outside consultants• Ability to write Validation Master Plans, IQ, OQ, PQ and PV Protocols• Management of Change Control ProgramColgate Palmolive is a global supplier of oral care, personal care, home care and pet nutrition products. In this position I maintain the state of compliance of validation program, to assure that it meets the regulatory requirements of the FDA for the OTC drugs manufactured by the company. I also manage the change control program at the plant to assure that the validation status of the equipment and processes are maintained.

Spring Valley, New York

• Execution of Performance Qualifications and Process Validations • Ability to write Performance Qualification and Process Validation reports• Knowledge of GMP procedures, ANSI/ASQC sampling procedures as well as FDA regulationsPAR Pharmaceutical is a pharmaceutical manufacturer with ninety generic prescription products and two branded products. In this position I designed a qualification / validation program for the existing packaging lines and a newly constructed packaging area.

Totowa, New Jersey

• Execution of Performance Qualifications and Process Validations • Resolution of qualification / validation deviations• Management of consultant resources and special projects• Training of personnel supporting qualification / validation studies• Knowledge of RFID technologyPurdue Pharma is a pharmaceutical manufacturer with seven prescription medicines and ten nonprescription products. I reviewed and approved requests to proceduralize qualified equipment settings and revise packaging batch records. I also coordinated the qualification of newly constructed packaging lines and the validation of new products and process modifications.