Danielle Giles Email and Phone Number
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The opportunity to work in Quality Assurance in various companies and for many different roles has given me a wide perspective of how the Quality Management System (QMS) touches every aspect of product manufacturing and release, including continuous improvement. I have QA Lead, QA Management, Technical Writing, and/or Project Management experience in the following areas:- Management, creation, and approval of documents from SOPs to policies, validation protocols to reports, white papers to marketing material, MBRs to release memos, Quality Agreements to customer complaint, and minor deviations to quality-impacting investigations, Technical Documents (MDR), risk reports, biological evaluations reports, DTMs, MOCs- Facility management such as equipment qualification, calibration and tracking, cleaning requirements, and work order review- QC activities including test method qualification and data/trend review- Creation and execution of IQ/OQ/PQs for software, process, and equipment validations- Product review and release from incoming materials to ERP system release to customer complaints- Ensuring investigations or deviations are written with adequate attention to root cause analysis and trending, proper CAPAs are initiated and tracked through effectiveness check closeout - Performing and hosting Internal, customer, supplier, and regulatory audits - Management Review Board presentations which track and trend the right data to provide appropriate and actionable continuous improvement- Electronic and manual document and record management systemsMy main areas of interest are QMS creation and improvement and Technical Writing. I understand the frustrations, time delays, and image impact associated with errors in documents, and I will save your company time and money by ensuring your documents are right-first-time. Let me help you with remediation activities, building or consolidating a new QMS, or to get that new project off the ground. I am available to travel up to 25% of the time with allowances made at the crucial times of big projects. In my other time, I love to adventure travel around the world. I hope my pictures and stories inspire others to travel wisely, too.
Rqm+
View- Website:
- rqmplus.com
- Employees:
- 394
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Rqm+Warwick, Ri, Us
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Project Consultant- QaRqm+ Oct 2018 - Sep 2024Monroeville, Pa, Us
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Director Of Quality AssuranceSeracare Life Sciences Aug 2016 - Oct 2017Milford, Ma, Us• Managed the Quality Specialist, Quality Engineering, and Document Control teams with an emphasis on building the teams, establishing intra- and inter-team collaboration, and ensuring the documents within the Quality Management System were written to meet regulation and internal specifications.• Successfully lead the Document Control team in a project to reduce the number of backlog documents waiting to be reviewed and approved from 1100 to 1 (per client request) while reducing the number of days in the lifecycle by actively involving all departments in the company. -
Manager, Quality Information SystemsAriad Pharmaceuticals, Inc. Jan 2015 - Mar 2016Cambridge, Massachusetts, UsManager, Quality Information Operations• QA lead for the development of the user requirements, process flow, and testing of an eQMS system to enable roll out of specific modules, including writing/reviewing and training of applicable procedures.• Managed, supported, and executed the implementation and life cycle management of a quality management system and the associated processes (policies, procedures, and practices).Manager, Quality Assurance Operations• Worked with cross-functional groups to map, improve and streamline processes such as batch release, including procedural updates and training. • Created template Quality Agreement to ensure GMP responsibilities were clearly delineated and worked with vendors to execute these agreements.• Served as QA lead for pre-commercial drug substance (API) and drug product projects.• Teamed with cross-functional group to implement new eQMS for initiating, tracking, trending, and reporting key indicators such as change controls and deviations. -
Quality SpecialistRhodes Pharmaceuticals Jan 2011 - Jan 2015Coventry, Rhode Island, Us• Successfully fulfilled contract position at Rhodes Pharmaceuticals L.P. and became FTE January 2012.• Partnered with CMOs, CPOs, CROs, and internal groups to review and approve executed batches and MBRs, change controls, deviations, protocols, and specifications.• Served as QA lead to bring projects through development and into commercialization; project leader for commercialized projects• Worked with the Quality Director and Specialists to create, edit, review, coordinate in QDCS and approve Quality Standards, SOP, Forms, and Templates for a start-up QA department.• Created and provided training such as Man-in-Plant training, SOP writing and reviewing, and QDCS utilization. -
Principal EngineerBaxter Pharmaceutical Solutions Llc Jun 2005 - Jun 2010Deerfield, Illinois, Us• Steadily advanced through a series of promotions to Principal Engineer role by driving QA Management approval of compliance documents (including SISPQ and non-SISPQ impacting exception reports, change control, and validation/qualification protocols and summaries), composing audit responses, and partnering with Manufacturing, Engineering, Maintenance and Sterility Assurance to achieve facility improvements. • Proficiently guided and assisted Quality Line Operations Associates to ensure business continuity and immediately resolve on-the-floor issues.• Championed introduction of visual board for exception reports to slash cycle time of non-SISPQ impacting exceptions from an average of 40 days to less than 15 days.• Diligently compiled and presented crucial metric data to senior management utilizing Microsoft Excel and PowerPoint applications, A3 reports, and cause-mapping diagrams. -
Validation SpecialistTheoris, Inc Sep 2004 - Jun 2005• Successfully completed consulting assignment focusing on authoring validation documentation such as Specifications, Qualifications (IQ, OQ, PQ), and Traceability Matrixes following GAMP 4 and 21 CFR 820. • Spearheaded planning and development of training program for new electronic manufacturing execution system.
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Analytical ChemistKelly Scientific Resources Aug 2003 - Oct 2004Troy, Michigan, Us• Resourcefully established and documented new analytical methods for cleaning validations in a 21 CFR 210 and 211 regulated environment. • Leveraged significant critical thinking abilities to evaluate scientific equipment and provided training to other analysts, exhibiting a strong team player work approach. -
Associate ScientistIndiana Protein Technologies (Ivax) Aug 2000 - Jul 2003• Wrote, reviewed and edited extensive paperwork such as SOPs, Forms, Policies, and investigations to achieve and ensure GMP compliance for start-up company. • Conducted research on new equipment to ensure 21 CFR Part 11 compliance, set up test methods, and trained other scientists in software use and proper procedures. • Exercised strong expertise in lab techniques to conduct a broad scope of analytical testing including HPLC, Electrophoresis, Western Blot, LAL, and TOC. • Utilized environmental monitoring equipment including air samplers, particle counters, and agar plates to accurately trend data and verified rooms stayed within USP (United States Pharmacopeias) limits; assessed, characterized and recorded contaminates. • Employed a constant commitment to cost control in evaluating suppliers and streamlining ordering and receiving process, subsequently saving company thousands of dollars.
Danielle Giles Skills
Danielle Giles Education Details
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Temple UniversityQa/Ra In Pharmaceuticals -
Ball State UniversityBiology
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Salem State UniversityWeb Design
Frequently Asked Questions about Danielle Giles
What company does Danielle Giles work for?
Danielle Giles works for Rqm+
What is Danielle Giles's role at the current company?
Danielle Giles's current role is Open to QA/RA consulting positions in medical device/pharma, including Technical Writing, QMS updates, MDR/regulatory compliance, investigations, validations, audits, and oversight. Full-time, part-time, short term..
What is Danielle Giles's email address?
Danielle Giles's email address is da****@****ing.com
What schools did Danielle Giles attend?
Danielle Giles attended Temple University, Ball State University, Salem State University.
What skills is Danielle Giles known for?
Danielle Giles has skills like Gmp, Validation, Proofreading, Pharmaceutical Industry, Sop, Biotechnology, Editing, Quality Assurance, Aseptic Processing, Quality System, Technical Writing, V&v.
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