Danielle Strong Email & Phone Number

Newton, Nj, Us

Newton, New Jersey, United States

Newton, New Jersey, United States

Newton, Nj

Middlesex, Nj

•Conduct supplier quality audits at various vendor facilities to review their compliance with cGMPs and ISO 9001:2008 accreditations and work closely with vendors to negotiate expectations•Evaluate potential product impact when component defects occur during production, work with cross functional groups to identify root cause, and implement corrective and preventive actions•Established controls for labeling material, working closely with Regulatory Affairs to maintain the current master… Show more •Conduct supplier quality audits at various vendor facilities to review their compliance with cGMPs and ISO 9001:2008 accreditations and work closely with vendors to negotiate expectations•Evaluate potential product impact when component defects occur during production, work with cross functional groups to identify root cause, and implement corrective and preventive actions•Established controls for labeling material, working closely with Regulatory Affairs to maintain the current master forms, developing additional verifications when issuing labeling material to production, and creating reconciliation requirements Show less

•Collaborated with cross functional team members to investigate deviations from protocols, standard operating procedures, change controls, and production batch records and develop corrective and preventive actions to prevent reoccurrence•Provided Regulatory Compliance trend reports for product investigations which was then incorporated into the Annual Product Review•Developed an environmental monitoring program for the site by interpreting USP and ISO guidelines and selecting contract… Show more •Collaborated with cross functional team members to investigate deviations from protocols, standard operating procedures, change controls, and production batch records and develop corrective and preventive actions to prevent reoccurrence•Provided Regulatory Compliance trend reports for product investigations which was then incorporated into the Annual Product Review•Developed an environmental monitoring program for the site by interpreting USP and ISO guidelines and selecting contract laboratories Show less

• Conduct toxicokinetic analysis on bioanalytical data to interpret and report parameters such as Cmax, Tmax, AUC, and R for GLP and non-GLP studies.• Collaborate with the bioanalytical staff to ensure compliant transfer of data and timely commencement of analysis.• Review all relevant TK components of protocols for consistency and adherence to applicable SOPs.• Serve as liaison for all TK related issues pertinent to the development of assigned drug candidates.

•Ensure quality of Toxicokinetic studies conducted within Drug Metabolism including adherence to relevant protocols, SOPs, GLPs, and internal TK standards•Propose resolutions to discrepancies noted through Quality Assurance audits•Review calibrations performed on equipment used in the Bioanalytical Laboratory•Proficient in the use of appropriate computer software (PKS, WinNonLin, LIMS)

•Managed suppliers of primary, secondary, and tertiary components for pharmaceutical and consumer products•Reviewed all data produced during incoming inspections and implemented improvements to SOPs and relevant forms•Provided timely closure of investigations involving component defects and ensured corrective actions were completed as scheduled•Completed cGMP Training for Auditors with emphasis on applying industry standards to auditing techniques•Motivated and developed direct… Show more •Managed suppliers of primary, secondary, and tertiary components for pharmaceutical and consumer products•Reviewed all data produced during incoming inspections and implemented improvements to SOPs and relevant forms•Provided timely closure of investigations involving component defects and ensured corrective actions were completed as scheduled•Completed cGMP Training for Auditors with emphasis on applying industry standards to auditing techniques•Motivated and developed direct reports utilizing personalized approach•Completed Talsico training on Human Error Reduction Show less

•Wrote and conducted validations for testing methods, equipment, and media used within the microbiology laboratory•Authored Standard Operating Procedures to comply with relevant regulatory compendia•Involved with Process Excellence as a team member of a Green Belt project•Responsible for training new analysts on microbial test methods

•Demonstrated and explained proper gowning techniques in a video used for training aseptic personnel•Performed environmental monitoring for aseptic and non-sterile processing areas•Responsible for challenging product stability via Antimicrobial Effectiveness Testing•Performed USP Sterility Testing utilizing Carlisle Barrier Systems

Assigned to Pfizer Global Manufacturing•Tested purified and non-purified waters with membrane filtration and pour plate methods•Prepared and challenged media used for microbial testing•Performed microbial limit testing on finished product, bulk, and raw materials•Familiar with and practiced cGMPs

Bs, Biology

Activities and Societies: THON Majored in Biology with a Vertebrate Physiology Option. Minored in Nutrition.

Education record