Cecille Vickers Email & Phone Number

Chino, Ca, Us

Irvine, California, United States

• Provides Quality leadership on new product project teams and ensures the Critical to Quality (CTQs) attributes cascading requirements (for user needs to product, process, raw materials and test methods) are established, implemented and met.
• Provides Quality leadership on new product validation programs to ensure they are well-defined, executable, meet customer and business needs, and are in compliance with regulatory requirements.
• Partners with new product project teams to ensure compliance with current quality system procedures including risk management, design controls, and process validation.
• Leads activities associated with risk management to ensure effective risk management to prevent failure modes and improve capability of processes
• Proactively examines systems, processes, and standards to identify areas for review, change, or elimination.
• Supports the development of more junior staff and advise management on technical matters
• Conducts quality evaluation for the development and validation of test methods.
• Collaborates with functional business partners to proactively address quality issues during new product development and product verification/validation. Ensures process capability with respect to product specifications.
• Adheres to safety and environmental policies and procedures and supports departmental safety and environmental objectives.

Santa Ana, Ca

• Review and maintain the final sterilization program for all of the regional sites. • Work with complaints group to develop systematic method of identifying potential microbiological related complaints.• Assure system evaluates risk to patient and makes appropriate recommendations to senior management in timeframe consistent with risk. • Support the product development process by providing input related to process and product design mitigations related to microbiological risks. • Responsible for compliance with applicable Corporate and Divisional policies and procedures. • Plans, executes, reports and follows-up on quality system audits (supplier and internal). • Actively participates in and supports departmental operations and responsibilities in accordance with existing internal procedures and external regulations.• Lead and/or facilitate group compliance activities associated with the quality system (e.g. audit programs, personnel training). • Monitors compliance with company policies, procedures and applicable regulatory requirements. • Makes decisions that are aligned with management objectives regarding work processes, plans and schedules in order to achieve department objectives. • Tracks and reports progress across projects and departmental commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans. • Resolves project issues by working with team members, project customers, and others as appropriate. • Assists department and project leaders in developing and reporting appropriate performance and quality metrics. • Demonstrates an ability to apply, recommend, create or innovate quality tools and apply them effectively to a variety of business situations related to work and team environments.

Costa Mesa, Ca

Responsible for management of activities related to quality and distribution in support of manufacturing, sales, engineering and the Quality System by performing the following duties personally or through subordinate supervision.• Inspection and final audit release• Receiving and Receiving Inspection• Shipping and finished goods warehouse functions• Packaging• Internal Quality audits• Supplier audits• Initiates ECN’s for existing products• Responsible for coordinating and prioritizing the work in inspection, receiving inspection and packaging to facilitate a smooth work flow, in support of schedules and customer commitments• Initiate MRB meetings as required• Complaint handling (PSR)• Maintain Quality Records• Quarterly Management review meetings• NCMR review meetings• Management Representative for quality

• Responsible for the cleaning validation/verification program, environmental monitoring program and sample control group.• Guide and direct groups which comprises of 2 chemists, 3 microbiologists and 7 laboratory technicians in the performance of their duties; manage work schedules; review, evaluate, and participate in work activities; and perform related duties as assigned. • Chair of the Watson Corporation Environmental Monitoring Harmonization Committee to harmonize microbiology methods company-wide.• Assist Production, QA, and other laboratory personnel with technical and/or process problems.• Solve problems, evaluate/review data, accurately check notebooks and logbooks on a regular basis, inform analysts of required corrections ensuring completion in a timely manner.• Enforce safety and cGMP polices within the laboratory.• Write and/or update SOP’s and test methods as needed.• Write protocols and reports for method transfer or development of microbiological methods.• Ensure that staff is properly trained and comprehends all updated SOP's, and test methods.• Initiate and conduct laboratory OOS investigations and write reports. Implement corrective and preventive actions.• Evaluate the performances of staff members and recommends promotion as appropriate.• Developed environmental monitoring module for the Laboratory Information Management System (LIMS).