Danielle Miner work email
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Danielle Miner personal email
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I'm an accomplished Lab Informatics Manager and Senior Validation Engineer with over 18 years of experience in cross-functional technical leadership, operational excellence, and complex project management in the pharmaceutical and biotech industries. I have extensive experience in building and leading top performing teams, developing process improvements, and global system development. I enjoy building valuable partnerships and work well with people at all levels of the organization. Technical Skills: ➤ Software & System Experience – Labware LIMS V5, V6, V7. V8, Infinity QS, TechnoSolutions TopTeam, Delta-V, Documentum, LabVantage LIMS, Agilient OpenLab, HP Quality Center (HPLM), HP Service Center, ETQ (Trackwise), MIDAS➤ Specific System Training – LabWare LIMS V5 System Admin, LabWare LIMS ELN, Aglient OpenLab System Admin, SmartLab System Admin, Scrum Master, CSM✉ miner.dani@gmail.com
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Senior Validation EngineerLabware Apr 2021 - PresentWilmington, Delaware, Us➤ Certified LabWare LIMS Consultant.➤ Successfully completed several major LIMS validation projects based on GAMP and industry SDLC standards.➤ Facilitating scoping studies to gather requirements based business processes for potential LabWare clients.➤ Developing updated internal documentation (manuals and requirements) to improve.➤ Collaborating with management to improve project quality gates and delivery to ensure successful product implementation.➤ Created and presented validation topics (Data Integrity, Importance of Requirements) at LabWare’s Customer Education Conference (CEC). -
Lab Informatics Manager & Ots ManagerCovex, Llc Jan 2014 - Mar 2021➤ Directly managed 5-6 employees within the Laboratory and Informatics Service Line to ensure optimal performance.➤ Provided oversight to the training, motivation, and objective fulfillment for each member's assigned client objectives.➤ Demonstrated exceptional technical leadership and hosted bi-weekly 1:1 meetings with direct reports to improve results.➤ Developed and managed lucrative client relationships while identifying new clients to expand company client portfolio.➤ Collaborated with Marketing and Sales by assessing client LIMS needs and providing salient, tailored recommendations.➤ Identified potential promising candidates for upcoming informatic projects, including an internal remote testing team of 19.➤ Skillfully managed and tracked a portfolio of a million dollars between 5 clients and improved communication channels.
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Senior Validation EngineerVerista Jan 2006 - Mar 2021Fishers, Indiana, Us➤ Successfully spearheading major LIMS validation projects with critically important clients, including Pfizer, JnJ, and Merck.➤ Leading and developing top-performing project teams, ensuring deliverables, and maintaining various LIMS versions.➤ Producing low-defect, consistent results that helped build exceptional client relationships and improve profitability.➤ Building strong relationships and collaborating cross-functionally at client sites including a consent decree environment.➤ Ensuring high quality by analyzing and testing the software and procedures used to manufacture clients’ products.➤ Performed business analyst roles, served as the defect author and manager, and led training for all LIMS team members.➤ Collaborating cross-functionally with QA in the routing, delivery, and deployment of various business critical projects.➤ Facilitating business risk assessments, leading requirements gathering, and developing IQ, OQ, and PQ test plans/scripts. -
Labware Glims Validation Process LeadPfizer Feb 2017 - May 2020New York, New York, Us -
Labware Lims Validation LeadJohnson & Johnson Dec 2011 - Mar 2020New Brunswick, Nj, Us -
Sap Validation LeadPfizer Pharmaceuticals Feb 2011 - Jan 2012New York, New York, Us -
Labware Lims Senior Validation EngineerWyeth Pharmaceuticals Jul 2006 - Oct 2009New York, New York, Us
Danielle Miner Skills
Danielle Miner Education Details
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Temple University School Of PharmacyRegulatory Affairs & Quality Assurance -
Penn State UniversityMinor In Business & Liberal Arts
Frequently Asked Questions about Danielle Miner
What company does Danielle Miner work for?
Danielle Miner works for Labware
What is Danielle Miner's role at the current company?
Danielle Miner's current role is Senior Validation Engineer at LabWare.
What is Danielle Miner's email address?
Danielle Miner's email address is mi****@****ail.com
What schools did Danielle Miner attend?
Danielle Miner attended Temple University School Of Pharmacy, Penn State University.
What skills is Danielle Miner known for?
Danielle Miner has skills like Validation, Computer System Validation, 21 Cfr Part 11, Gxp, Change Control, Lims, Quality Assurance, Capa, Gamp, V&v, Glp.
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