Senior Manager Quality Assurance

CHRISTIE LAMBERT

****************@*****.*** 304-***-**** Morgantown, WV 26508

Summary

Operations Leader at Fairmont, WV. Proactive, performance-driven professional with 23 years of progressive leadership. Skills

• Proficient in SAP

• SME - Quality Assurance

• Trackwise Program SME

• Documentum Expert

• Training material development

• Staff managing and mentoring

• MS Applications proficiency (PP, Excel, Teams)

• Safety procedures

• QA Label Specifications

• Correction plans

• Mastery of QA Methodologies

• Technical Investigation Writing

• FDA response team

• Pharmaceuticals Manufacturing and Quality Expert Experience

Novelis

Fairmont, WV

Operations Leader

2022 - Current

KVK Tech, Pharmaceuticals

Newtown, PA

Senior Manager – Labeling and

Packaging Operations

2021 - 2022

Viatris (Mylan Pharmaceuticals)

Morgantown, WV

Senior Manager – Packaging Operations

2020 - 2021

•Manage a team of 7 management employees and 160 bargaining unit employees

• Responsible for developing, implementing, managing operations and processes systems to ensure high level efficiency and customer satisfaction

• Leading producer of special flat-rolled aluminum in the world’s largest recycler

• Team Lead on the implementation of SAP

• Manage a team 6 management employees and 3 shifts in Labeling and Packaging Operations

• Oversee all Labeling Revisions, FDA launches, Packaging Batch Records

• Conduct cGMP, SOP and Safety Training sessions to management and shop floor employees

• Manage a team of 8 management employees and 230 + bargaining unit employees.

• Monitor SAP Process Order statuses for shop floor readiness

• Oversee the Manufacturing Batch Records, Recipes, Packaging Control Sheets and Labeling components for FDA compliance.

• Establish productivity improvements through writing incident investigations in Trackwise. Identify and implement CAPA (Corrective Action/ Protective Action) for incident resolution and process improvement.

• Conduct cGMP, SOP, and Safety Training Sessions to management and shop floor personnel to stay within EH&S compliance.

• Supervise Process Instructions (PI sheets) in SAP for Packaging Execution.

• Steer Packaging Schedules for functional location, equipment, and material execution.

• DEA Potency Suite and Class II drug control.

Mylan Pharmaceuticals

Morgantown, WV

Senior Manager – Quality Operations

2012 - 2020

• Managed Mylan’s Label Control department, responsible for 12 management and 76 bargaining employees.

• Floor Lead for Label Control and Quality Operations for Packaging.

• Executed Mylan’s SAP Ordering, Receiving, Releasing, and Destruction of controlled labeling.

• Led QA Operations department through 5 FDA inspections.

• Worked with Quality and Packing Operations to implement Serialization/Track and Trace for compliance of the DQSA (Drug Quality Security Act) mandate of prescription drugs sold in the US.

• Monitored all paper Batch Record information to SAP Process Order/Instructions for Quality Operations.

• Managed Mylan’s batch records for QA departments for FDA compliance.

• Controlled FDA Regulatory labeling submissions and implementation dates.

• Remediation Lead for Label Control Quality and Packaging. Mylan Pharmaceuticals

Morgantown, WV

Manager – Quality Operations

2007 - 2012

• Managed Label Control Packaging Schedule adherence.

• Responsible for the implementation of FDA Regulatory labeling submission.

• In charge of labeling inventory (receiving, releasing, and destruction) for Morgantown site.

Mylan Pharmaceuticals

Morgantown, WV

Supervisor and Senior Associate

Label Control

2000 – 2007

• Supervised day shift bargaining employees.

• Material availability checks for upcoming batches.

• Approved material label artwork for FDA submissions.

• Wrote technical descriptions for packaged finished dose material.

• Complied with GMPs, FDA and USDA regulations to produce safe products for consumers.

Education and Training

Bachelor of Arts and Science, August 1999 (Teaching); 12 Hours Master Credit West Virginia University ROLD Regional Operations Leadership Development Novelis OSHA PPE Certified Mylan Pharmaceuticals

CGMP Training Mylan Pharmaceuticals

SOP Training Mylan Pharmaceuticals

Honors and Activities

• WVU Mountaineers Women’s Basketball Team, 1994 - 1999

• Horseback riding

• Playing basketball

• Cornhole champion

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