Desiree Doss Email & Phone Number

Cleveland, OH, US

Copenhagen, DK

• Responsible for MQA support personnel management, training, employee growth and development and conducting performance reviews.
• Review batch records and associated documentation, including environmental monitoring and QC data, to ensure compliance for release.
• Work with multiple departments to resolve issues found during documentation review including initiation and assistance with investigations of deviations associated with batch release.
• Lead weekly cross functional batch release meetings to ensure timelines are met for release of products.
• Determine and perform final disposition of batches and ensure all products released for distribution are in compliance with site procedures, regulatory and cGMP guidelines.
• Prepare monthly site and global KPI metrics related to batch record review and release process.

Copenhagen, DK

• Reviewed batch records and associated documentation, including environmental monitoring and QC data, to ensure compliance for release.
• Worked with multiple departments to resolve issues found during documentation review including initiation and assistance with investigations of deviations associated with batch release.
• Led biweekly cross functional batch release meetings to ensure timelines are met for release of products.
• Determined and performed final disposition of batches and ensure all products released for distribution are in compliance with site procedures, regulatory and cGMP guidelines.
• Prepared monthly KPI metrics related to batch record review and release process.
• Established procedures and other documents for CMO manufacturing.

Copenhagen, DK

• Serves as an integral member of the quality assurance team that helped the site obtain FDA approval under a modified Consent Decree. Assists in the implementation and improvement of the quality systems in a start up.
• Provide on-the-floor quality oversight to sterile and non-sterile operations.
• Review and approve, SOPs, protocols, logbooks and validation reports.
• Approve use and issue material for use in JD Edwards.
• Ensure compliance to procedures and proper aseptic technique by observing and coaching operators during manufacturing activities.
• Use Trackwise system to initiate and author deviations and investigations, CAPAs and change controls.

Waltham, MA, US

• Performed manufacturing batch record and QC data audits for compliance to processes, procedures, and ensures completeness and accuracy of documentation prior to product release, reject and/or lot disposition
• Performed Deviation and Corrective and Preventive Action activities including but not limited to control of nonconforming material
• Assisted with investigations and internal audits
• Provided training for new hires in quality elements like good documentation practices and quality policies
• Performed incoming, intermediate, and finished product release functions
• Assured compliance to in-house and/or external specifications and standards, such as Quality System Regulations and ISO regulations (ISO 13485 and ISO 14971, Application of Risk Management to Medical Devices).

Santa Clara, California, US

• Performed bulk filling operations of clinical and commercial products by operation of automated and semi-automated filling equipment and manual pipette dispensing
• Ensured batches manufactured contained proper ingredients and quantities
• Adhere to SOPs to perform dispensing, labeling and final product assembly and properly handle, store, package and distribute final products
• Participated collaboratively as part of large and cross-functional project teams

Ingelheim Am Rhein, Rhineland-Palatinate, DE

• Independently executed all routine unit operations in filling including change-over procedures, weight checks, equipment cleaning and setup while maintaining good aseptic techniques necessary in clean room environment
• Assisted senior technician in identifying and correcting root cause problems to decrease downtime and increase productivity
• Established and maintained procedures related to the current Good Manufacturing Practices (cGMPs) training requirements of the Quality System Regulations that meet FDA CFR 21 requirements
• Facilitated corrections and reviewed documentation to keep department in compliance with Good Documentation Practices to aid quicker release of drug products
• Attended trainings for and participated in launching and maintaining a 5S project in production areas and the warehouse
• Trained junior staff on unit operations such as filling and preparation activities