Danielle Giles Email & Phone Number

Warwick, RI, US

Monroeville, PA, US

Milford, 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.
• 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.

Cambridge, Massachusetts, US

• Manager, 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.

Coventry, 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.

Deerfield, 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.
• 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.

• 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.

Troy, 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.

• 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.
• Employed a constant commitment to cost control in evaluating suppliers and streamlining ordering and receiving process, subsequently saving company thousands of dollars.

Master'S Degree, Qa/Ra In Pharmaceuticals

Bs Degree, Biology

Certification, Web Design