Pamela Denolf Email & Phone Number

Indianapolis, In, Us

Riverview, Michigan, United States

Ferndale, Michigan, United States

Ann Arbor, Michigan

Melrose Park, Illinois

Perform cross functional non-conformance investigations and implement effective corrective actions.

Melrose Park, Illinois

Supervise 3-4 member compliance teamCompose, review and approve complaint investigationsWrite Field Alert investigations for submission to the FDACompile and present key quality metricsLiaison for regulatory, customer and regional audits

Investigate customer complaintsCompliance AuditingStability program oversiteFailure Mode and Effect Analysis, Quality by design, Risk managementQuality Assurance representative for product developmentDeviation investigation writing and corrective action/preventative action facilitator

Rochester, Michigan

Promoted to Supervisor to develop, focus and train newly formed Quality Operations group. Managed a 2-4 person staff to oversee raw material dispensing, equipment preparation, formulation, sterile filling, product inspection and packaging and the distribution center.•Consistently reviewed a minimum of 95% of in-process documentation on the manufacturing floor to assure compliance with batch records, SOPs and regulations with the goal that corrections could be made immediately.•Assisted and wrote technical evaluations for investigations, corrective action / preventative actions, and planned process modifications. Updated / reviewed SOPs and Master Batch Records.•Created weekly audit program for 10 manufacturing areas to verify cleanliness, adequate signage, and equipment calibrations were up to date to support the “Audit Ready All the Time” KPI. •Participated in Operational Excellence and continuous improvement projects: EMEA Annex 1 Capper Upgrades; Building Automation System Upgrades; Clinical Filler Installation; Controlled Temperature Redundancy Evaluations and Refrigerator Installation; Classification of Equipment for Criticality.•Actively monitored personnel to verify actions were in accordance to current Good Manufacturing Practices and Health and Safety programs.

-Assure batch records conform to cGMPs, established standards and specifications prior to approval -Conduct, write and approve investigations related to batches, equipment, and customer complaints-Review in-process data during manufacturing operations in Inspection, Packaging and Bulk manufacturing -Communicate with contract customers regarding closure of investigations and batch release

Systems and Documentation -Responsible for coordinating change controls which updated Laboratory Procedures, Material Specifications, Forms and Standard Operating Procedures-Compile and proof read data for Annual Product Reviews-Write and distribute reports using MS Word, MS Excel, MS Access

Lloyd A. Stage Nature Center-Coordinate nature center educational activities and gift shop-Organize data bases using MS office programs, answer phones and work with the public

-Accountable for internal audits to ensure fulfillment of cGMPs, SOPs, and regulatory requirements-Act as company liaison for all regulatory, contract customer, and corporate audits-Conduct vendor audits and work with Incoming Quality to resolve vendor issues

-Perform a variety of sterility, microbiological, and particulate matter testing of pharmaceutical products and raw materials-Participate in special projects, investigations, and revise laboratory procedures and SOPs

Conducted and published research pertaining to food poisoning microorganisms