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Isn’t it amazing how certain events can be imprinted in our memories, influencing decisions we make years down the road? Close to twenty years ago, I was sitting in a crowded rec hall waiting with equal parts anticipation and nerves to receive my diploma; a piece of paper that was earned over a slew of late nights, a few tears, and loads of moments learning how to learn.Close to a week later, I was sitting in a crowded conference room waiting again with anticipation and nerves for my first team meeting to begin. I remember that our leader had a monogram on his shirt. I remember how confidently he spoke about the plans for the week ahead. Most importantly, I remember how he had the undivided attention of everyone around the table. He had gained the respect of the entire team. The years following came with several forks in my career path, one company merging with another, one company buying another, the desire to be closer to home for my two small children. Along the way, I was fortunate enough to experience several more examples of leaders exhibiting traits I hoped to emulate.It is that collection of experiences that has molded me into the leader I am today. I’ve learned to identify and develop strengths in teammates. I’ve learned to connect the unique strengths of teammates to solution a complex problem. I’ve learned to unravel a complex problem into smaller, focused elements. I’ve learned the focus and discipline required to fully execute a sustainable solution that addresses the root cause, not the symptoms.Most importantly, reflecting on that first team meeting of my career, I’ve learned that we all respected and supported our leader because of one simple thing; he respected and supported us.
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Vp Quality And ComplianceThorlabsNewton, Nj, Us -
Vp Global Supply ChainThorlabs Aug 2023 - PresentNewton, New Jersey, United States -
Director Of Quality And ComplianceThorlabs Feb 2021 - Aug 2023Newton, New Jersey, United States -
Director Strategic InitiativesThorlabs Aug 2016 - Feb 2021 -
Quality ManagerThorlabs Jun 2014 - Aug 2016Newton, Nj -
Supplier Quality EngineerThorlabs Jan 2013 - Jun 2014 -
Incoming/ Supplier Quality Assurance ManagerCorepharma Llc Jun 2012 - Dec 2012Middlesex, Nj -
Incoming Quality Assurance SupervisorCorepharma Llc Jul 2011 - Jun 2012•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 -
Product Assurance SpecialistCorepharma Llc Nov 2010 - Jul 2011•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
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Scientist IMerck Nov 2009 - Sep 2010• 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. -
Scientist ISchering-Plough Research Institute Dec 2007 - Nov 2009•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) -
Team Leader, Incoming QualityMcneil Consumer & Specialty Pharmaceuticals Jun 2007 - Dec 2007•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 -
Qc MicrobiologyMcneil Consumer & Specialty Pharmaceuticals Dec 2006 - Jun 2007•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 -
Qc MicrobiologyPfizer Feb 2003 - Dec 2006•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 -
Qc MicrobiologyManpower Inc. May 2002 - Feb 2003Assigned 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
Danielle Strong Skills
Danielle Strong Education Details
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Biology -
Krhs
Frequently Asked Questions about Danielle Strong
What company does Danielle Strong work for?
Danielle Strong works for Thorlabs
What is Danielle Strong's role at the current company?
Danielle Strong's current role is VP Quality and Compliance.
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What schools did Danielle Strong attend?
Danielle Strong attended Penn State University, Krhs.
What skills is Danielle Strong known for?
Danielle Strong has skills like Gmp, Sop, Capa, Validation, Glp, Quality Assurance, Pharmaceutical Industry, Fda, Change Control, Lims, Quality Control, Cross Functional Team Leadership.
Who are Danielle Strong's colleagues?
Danielle Strong's colleagues are Julien Vigroux, Kaitlin Hoffmann, Glenn Curcione, Axel Probst, Shah Bano, John Granger, Tom Casserly.
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Danielle Strong
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