Process Improvement Quality Compliance

Misty Lynn Thomas

Indianapolis, Indiana 641-***-****

************@*****.***

SUMMARY

A resourceful and Quality Representative professional with demonstrated experience in supporting alignment and improvement initiatives, participating on cross functional teams to address process improvement, system improvement and new regulations/ expectations. Excels at implementing effective changes to drive achievement of key corporate objectives. A key leader who coordinates skillfully with team members and management to troubleshoot issues, develop, and implement lasting solutions, and deliver consistent results.

EXPERIENCE

INCOG BioPharma Services

Fishers, Indiana

Quality Compliance

Specialist 2024-Current

· Perform primary generation and review of supplier evaluation documentation, including supplier evaluations, questionnaires, and audit reports.

· Perform primary generation and review of supplier corrective action request (SCAR) documentation and follow through to closure.

· Perform generation and review of quality agreements between suppliers and INCOG.

· Perform review of material specifications.

· Perform internal audit planning and tracking of mitigations.

· Support External/Third party audits.

· Support recalls and complaints activities.

· Support Annual Product Review activities.

· Generation and review of regulatory surveillance activities using Redica platform.

· Ability to manage multiple projects in a fast-paced environment.

Experience with executing or providing oversight for supplier qualification activities for FDA/EMA regulated aseptic manufacturing facilities. Certified Quality Auditor, or equivalent.

· Experience with performing audits of internal and external sites/functions.

CATALENT PHARMA SOLUTIONS Bloomington, Indiana

Senior Quality Assurance Representative 2022- 2024

Requires in-depth knowledge and experience.

Uses best practices and knowledge of internal and external business issues to improve products and/or services.

Solve complex problems; takes a new perspective using existing solutions.

Works independently and receives minimal guidance.

Acts as a resource for colleagues with less experience,

Competent at-risk mitigation for function.

May lead functional teams and projects.

Accountable for the Investigation and CAPA Management Systems.

Responsible for managing complex and high-level deviations, supporting OOS investigations, and collaboration with internal stakeholders to support the effective execution of the Investigation and CAPA systems.

Maintains and enhances effectiveness of the Quality System, including developing and reporting metrics, identification, and implementation of improvement opportunities for established Quality Systems, processes, procedures, and training to support Deviation, Out-of-Specification and CAPA processes.

ST Pharmaceutical Services LLC Dupo, Illinois

Quality Compliance Specialist 2020-2022

•Manage and supervise the Quality Compliance Document Control Coordinator

•Ensure that all aspects of product (raw, intermediate, final) release meet analytical, production, packaging and labeling specifications in accordance with established quality systems.

•Review Root Cause Analysis investigations and ensure adequate CAPAs are put in place to reduce or eliminate recurrence of issues.

•Documentation control including write, review, or approve Operation Procedures, Specifications, Master Manufacturing Procedures and other QA-controlled documents.

•Participate in internal audits as needed.

•Interact with the production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.

•Respond to quality-related customer questions.

Alkem Laboratories Fenton, Missouri

Associate Supervisor 2015-2020

•Supervise employees utilizing automatic/manual equipment to perform operations to dispense, manufacture, fill and package products, including but not limited to, finished pharmaceutical goods

•Supervise daily operation of production department ensuring schedules are met, equipment is optimized and staffed to maximize productivity

•Ensure products are manufactured and packaged according to Master Batch Records and current Good Manufacturing Practices (cGMP)

•Provide on the job training to employees and maintain the training records for all manufacturing employees

•Participate in nonconformance investigations using root cause tools such as: 5 whys, Is/Is Not, and 6M analysis

•Develop CAPA plans based on the information obtained from the RCA

•Ensure materials are being requested and supplied to the manufacturing department to meet production schedules

•Ensure Logbooks, Batch Records, and Protocols are being written, reviewed and approved in a timely fashion

•Schedule equipment for preventative maintenance and calibration

Zoetis (A Division of Pfizer) Charles City, Iowa

Operator III (Shift Lead) 2011-2015

•Delegate job assignments to all operators in the department and ensure all tasks are performed in a timely matter

•Review, revise batch records, SOP’s, etc. then train operators to execute

•Perform general equipment setups for production equipment preparation

•Perform maintenance/troubleshooting and cleaning of equipment and facilities

•Complete Supervisor/Management directed projects and special assignments as required

•Schedule equipment for preventative maintenance and calibrations

•Conduct cGMP and safety classroom training for coworkers

•Perform environmental monitoring utilizing particle counters, viable counters, and contact monitoring

•Perform Safety Audits and conduct Job Safety Assessments

Lutheran Services in Iowa, Charles City, IA 2009 - 2011

Community Service Specialist

North Iowa Community Action Organization, Charles City, IA 2008 - 2009

Early Head Start Home Visitor

KinderCare Learning Centers, Bourbonnais, IL 2002 - 2008

Program Specialist

Riverside Medical Center, Kankakee, IL 1997 - 2002

Mental Health Tech/School Age Teacher

EDUCATION

Governors State University 2006

Bachelor of Arts

Kankakee Community College 1996

Associate Liberal Arts

References and Additional Information Available Upon Request

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