Errol Williams Email & Phone Number

Denver, CO, US

Danvers, Massachusetts, United States

Colorado, United States

Boulder, Colorado

Responsible for the management of suppliers within the Surgical Innovations Business Unit, with accountability to support selection, approval and qualification of new suppliers or changes to existing supplied products and processes, as well as oversight of performance and improvement activities. Also, lead the oversight of supplied products, ensuring.

Boulder, Colorado

• Responsible for providing quality oversight and support for design change projects and sustaining engineering projects as well as to Contract/OEM suppliers for the Boulder facility.
• Uses engineering and quality expertise to guide project teams as the Quality representative on local cost savings projects as well as international projects.
• Reviews and approves documentation including protocols, reports, PPAPs, supplier change requests and SCARs.
• Provides quality system guidance to ensure compliance to SOPs and appropriate external regulatory standards to other engineering groups and project teams.

• Responsible for Quality Engineering oversight and support on 13 manufacturing/production processes.
• Provide quality review and approval on all site NCMRs.
• Author, review, execute, summarize and approve Computer Validation (MSCM), Process Validations (IQs, OQs, PQs), PVVPs, SOPs, SPECs, Engineering Studies, FMEAs (Process and Design), MSAs, First Article Verifications, etc.

Longmont, CO

• Responsible for providing QA oversight and support on over 1090 projects (capital/site).
• Led QA oversight on changes (process improvements) made to the FileMaker Pro database that supported the BMS/SCADA utility excursion alarm response at the Lake Centre manufacturing facility. Created process.
• Performed audits of Laboratory, Dispensing, Utilities and Validation groups. Also participated in third party audits
• Served as information liaison for regulatory inspections
• Reviewed and approved over 1050 CCMS records while ensuring alignment with Corporate, Site and Regulatory requirements
• Reviewed and approved over 1500 SOPs while ensuring alignment with Corporate, Site and Regulatory requirements

Lincolnton, NC

• Responsible for coordinating the validation plans and development of validation protocols. Selected as interim group lead the first year.
• Reviewed and approved document change control, engineering change control and all validation protocols
• Coordinated daily activities of the Technical Services group
• Assumed all Technical Services group budgetary responsibilities

Lincolnton, NC

• Responsible for process and cleaning validation, while also handling over 50 projects with little guidance. Leader of Engineering Change Control Quality System Management Team
• Authored and executed process and utilities validations
• Trained junior quality/validation engineer members in process validation, equipment validation and cleaning validation/verification
• Successfully managed 3 high profile projects for on-time completion at a Solid/Oral Dose Fill/Finish facility
• Leader of Engineering Change Control QSM Team

Lincolnton, NC

• Responsible for 45 projects under the supervision of a senior quality engineer
• Authored cleaning validation master plan
• Analyzed and solved cleaning validation method development problems
• Authored and executed process and utilities validations

Lincolnton, NC

• Responsible for testing raw materials per monograph and according to SOPs
• Performed IQ/OQ/PQ of Tekmar-Dorhmann Headspace Autosampler
• Installed and validated an HP 6890 plus GC
• Authored SOP on the Tekmar-Dorhmann Headspace Autosampler

Lincolnton, NC

• Responsible for testing finished products per monograph and according to SOPs
• Tested finished products and stability samples per monograph and in accordance with SOPs
• Trained associates on testing of finished products and stability samples per monograph and in accordance with SOPs