Melissa Newman
Bloomington,IN
Summary
Ambitious Quality Analyst with track record of dependability and leadership. Knowledgeable in QA and QC methodology with proven history of reducing errors to increase quality. Dedicated to providing consistent results to guarantee the safety, efficacy and timely release of products that help people live better, healthier lives.
Overview
26
26
years of professional experience
Work History
Quality Assurance Representative
Catalent Biologics
06.2022 - Current
- Review documentation for manufacturing activities associated with development and execution in accordance with current good documentation practices (cGDP), including but not limited to: executed batch records, master batch records, product labels, forms and other product specific documents
- Support the evaluation and lot disposition of intermediates and finished drug products
- Critically review various documentation types to ensure completeness, accuracy and compliance including but not limited to test methods, method validation protocols, reports and Standard Operating Procedures (SOPs)
- Contribute to process improvement of batch records and associated processes (e.g. turnaround times) to ensure all QA batch disposition deadlines are met
- Oversee status of batches through disposition/release process and remove barriers, communicate escalations as appropriate
- Communicate effectively with cross functional departments to ensure on time delivery of QA review and disposition responsibilities
- Collaborate with Manufacturing to resolve batch record discrepancies and errors as they relate to cGDP or Manufacturing Execution System (MES) inventory
- Participate in and support internal, client, regulatory and/or vendor audits to ensure all operations are in compliance with regulatory procedures and policies
- Participate in review and approval of deviations, corrective and preventive actions, vendor assessments, risk assessments, and nonconforming material reports
Quality Associate I
Baxter BioPharma Solutions
06.2021 - 06.2022
- Ensure compliance with all worldwide regulatory agency requirements
- In-process review of batch records and other documents involved in the aseptic processing of drug products to ensure that they are complete, accurate and compliant with current Good Manufacturing Practices
- Perform quality functions in classified areas, including production oversight, manufacturing process assessments and aseptic intervention oversight
- Review completed terminal sterilizer, lyophilizer, depyrogenation and autoclave charts
- Initiate and author Nonconformance Reports and Corrective and Preventative Action responses
- Collaborate with management teams to prepare for internal and external audits
- Conduct bi-annual inspections of classified areas in preparation for facility shutdown periods
- Initiate Standard Operating Procedure revisions as needed to support continuous improvement
- Assist with screening and interview of applicants during Baxter hiring events
- Serve on Baxter Safety Committee
- Addressed non-conformance issues, pausing production to correct errors.
- Recorded findings of inspection process, collaborating with quality team to implement corrective actions.
- Analyzed quality and performance data to support operational decision-making.
- Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.
Owner/Operator
Melissa’s Pet Sitting Service
04.2013 - 06.2021
- Responsible for all aspects of marketing and client acquisition
- Support and manage a client base of over 80 clients
- Care for a variety of animals, including dogs, cats, birds, rodents, reptiles and fish
- Ensure client security and privacy
- Perform all billing and accounting
Chemist II
Avon Products Inc
07.2009 - 04.2013
- Manage raw ingredient portfolio
- Qualify new raw materials and new raw material vendors
- Obtain and manage documentation from product suppliers to enable qualification of raw ingredients
- Manage the specification development and coding of novel ingredients
- Coordinate with safety, regulatory and quality departments throughout approval and specification development
- Manage and document reformulations from proposal through approval
- Manage retention and testing of raw ingredient samples
Analytical Technologist
Kolmar Laboratories
01.2006 - 03.2008
- Daily raw material, in-process, bulk, and finished product testing
- Operate analytical instrumentation such as HPLC, GC, IR, UV-Visible and X-Ray Fluorescence
- Review Out Of Specification events with follow-up
- Execute transfer protocols
- Train laboratory technicians
- Perform special project work as needed
Consultant
GlaxoSmithKline Pharmaceuticals/Smith Hanley Consulting
11.2005 - 09.2006
- For Analytical Science, Project Analysis, Classic and analytical testing of Active Pharmaceutical Ingredients for Chemical Development
- Operate analytical instrumentation such as HPLC, GC, IR, UV-Visible and X-Ray Fluorescence
- Regular use of analytical software including Electronic Notebook, Empower, Chemstation and iMAS
- Adapt and validate methods as needed for project support
- Record retention and archiving
- Provide support for the Upper Providence, PA pilot plant
- Work with the quality assurance group to prepare for FDA and CDQA Audits
- Perform regular safety and quality audits of laboratory facilities
- Serve on the GSK Red Cross blood drive committee and Biodiversity Team
Microbiologist, Quality Assurance Supervisor
Arch Personal Care Products
01.1998 - 03.2005
- Assume primary responsibility for quality of raw materials
- Develop new microbial audit and training methods for Rochester, NY plant
- Review customer questions/complaints regarding quality issues
- Review and correct quality issues in SAP database
- Microbiologist
- Sampling and microbial testing of incoming raw materials and final products
- Preservative efficacy testing
- Determine remedial actions, when required
- Audit of manufacturing and warehouse facilities
- Train manufacturing and warehouse personnel
- Provide additional coverage for analytical lab as needed
Education
B.S - Biology, w/Marine Science
Kutztown University
Kutztown, PASkills
- Quality Assurance: Quality Oversight of Manufacturing Areas, Record Review and Control, Batch Review, Facility Inspection, Nonconformance and Corrective/Preventative Action Report Initiation and Review
- Computer Software Applications: Trackwise, Documentum, Electronic Notebook, Empower, Chemstation, SAP and Microsoft Excel
- Analytical Chemistry: HPLC, GC, ICP, IR, X-Ray, UV/Vis, Wet Chemistry and Record Control
- Microbiology: Aseptic Technique, Standard Plate Count, Simple/Differential Stain, Preservative Efficacy Testing and Microbiological Audit of Facilities
- Other Skills: Self-motivated, Detail Oriented, Conscientious, Flexible with Strong Verbal and Written Communication skills
- Additional Experience: Quality Control, Records Control and Leadership/Supervisory Experience
Timeline
Quality Assurance Representative
Catalent Biologics
06.2022 - Current
Quality Associate I
Baxter BioPharma Solutions
06.2021 - 06.2022
Owner/Operator
Melissa’s Pet Sitting Service
04.2013 - 06.2021
Chemist II
Avon Products Inc
07.2009 - 04.2013
Analytical Technologist
Kolmar Laboratories
01.2006 - 03.2008
Consultant
GlaxoSmithKline Pharmaceuticals/Smith Hanley Consulting
11.2005 - 09.2006
Microbiologist, Quality Assurance Supervisor
Arch Personal Care Products
01.1998 - 03.2005
B.S - Biology, w/Marine Science
Kutztown University
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