Kendra L. Stewart-Brown
North Miami Beach
Summary
Dynamic professional leveraging expertise in the pharmaceutical, nutraceutical, biotechnological, and industrial chemistry sectors. Proven experience includes a wide range of formulations, such as oral solid dosage forms (controlled substances and dietary supplements), injectables, patches, and animal dietary supplements. Additionally skilled in developing blister tablet packs, food and beverage products, and medical devices. Committed to driving innovation and quality in product development while ensuring compliance with industry standards.
Overview
18
18
years of professional experience
Work History
Lab Tech Relief
Leprino Foods
Allendale, MI
12.2023 - Current
- I provide relief for Powder Tech, Micro Lab Tech, Raw Milk Tech, In-Process Lab Tech, Melt / Cheese Grading Lab Tech
- Certified by MMPA (Michigan Milk Producers Association)
- Perform chemical analysis on all final and in-process cheese products for pH, moisture, fat, and salt testing.
- Demonstrate proper method of cheese, milk, and whey Babcocks.
- Utilize the Flex, MES, and SAP applications to input chemistry results.
- Represent the Quality Execution Department during corporate, regional, or customer visits.
- Perform Bacti plating of cheese, whey, water, swabs and milk samples
- Perform Ether, Ash, Moisture testing on whey powder samples
Senior Regulatory Affairs Associate
Arnet Pharmaceutical
Davie, FL
01.2013 - 12.2023
- Authored scientific documents (Monograph / Leaflets, QQ's (Quali-Quantitative Formulas), Raw Material Specifications, CTD's, Certificate of Analysis, IPQC (In-Process Quality Control), Product Specifications, Specification Certificates, SPC's (Summary of Product Characteristics), etc.)
- Ensure raw materials are in compliance of FDA
- Ensure products are in compliance of label claims (Kosher, Halal, GMO, Allergens, etc.)
- Knowledgeable of international registration requirements for Dietary Supplements
- Review new formulations
- Perform internal and external audits, and in-house trainings / refreshers
- Authored deviations
- Apply for the Kosher and Halal Certification of manufactured products
- Developed and implemented strategies to ensure compliance with regulatory requirements.
- Created and maintained comprehensive databases of regulatory documents.
- Reviewed product labeling, advertising material, promotional literature and other marketing materials for accuracy and compliance with local regulations.
- Led regulatory submissions for new product approvals, ensuring compliance with FDA regulations.
- Developed and implemented regulatory strategies to expedite product lifecycle management.
- Mentored junior associates on regulatory processes and documentation requirements.
- Collaborated with cross-functional teams to align project goals with regulatory standards.
- Established best practices for risk management in regulatory submissions and audits.
- Managed the preparation and review of regulatory documentation, ensuring compliance with international guidelines and regulations.
- Prepared high-quality submissions for FDA approval, leading to successful product launches in a timely manner.
- Recommended improvements to processes.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Prepared and submitted regulatory file applications and supporting documentation.
Quality Assurance Document Control Specialist / Quality Assurance Inspector
Vital Pharmaceuticals VPX
Davie, Florida
06.2011 - 01.2013
- Issue and review batch records
- Authored and reviewed SOP's
- Maintain storage of all validation lots, commercial lots, logbooks and lab results
- I perform in process sampling on Capsules, Tablets/ Vitamins, Protein Bars, Energy Drinks/ Shakes and Powder blends in both stages: manufacturing and packaging and in-house audits
- I handled investigations on customer complaints, and recalls
- Release manufacturing rooms for production
- Perform environmental swabbing for micro testing
- Inspect and release product to the next process.
Manufacturing Process Technician II
Watson Pharmaceutical
03.2009 - 06.2011
- Set-up, operate and troubleshoot Bosch Checkweigher, and Bosch Encapsulator
- Verify correct information on batch records and logbooks insuring accessibility, organization of correspondence
- Operate Bosch Encapsulator, Checkweigher, Pan Coater, Fatte and Gemini Tablet Compressor collect routine samples of raw materials and perform in process sampling
- Knowledge of Blending (V-Shape and Slant Cone blenders), Glatt Fluid Bed Dryer, Laser Drill, Packaging and Imprinting
- Clean/ and inspect sample room as required per SOP and log
- Ensure compliance with all company policies and procedures, including safety rules, and regulations
- Open/close a batch record, set-up a new lot for production
- Major/minor clean of equipment
Quality Assurance Inspector / Manufacturing and Packaging Operator Line Lead
Schering-Plough Pharmaceutical Laboratory
09.2007 - 01.2009
- Assisted with the execution of validation protocols
- Authored protocols and prepared final reports that identify the results of protocol testing and the conditions of release
- Conducted efficiency studies for identification of process improvement opportunities
- Participate in handling multiple projects and coordinating activities
- Coordinated group work and build consensus among my team members for the production of six production lines including both packaging and manufacturing
- Interpret data point results as within control and out of control / specifications, and record data points on a control chart
- Managed complaints logs and tracked the completion of complaints
- Generated a completed annual product review for each product
- Involved in conducting daily, weekly, and monthly GMP audits and environmental monitoring
- Monitored raw material and intermediate review dates, expiration dates, and the vendor certification program
- Maintained Quality Unit databases to track and monitor status of materials (e.g
- JDE MRP system, Trackwise)
- Inspected, tested, and secured all materials and process in accordance with SOP's
- Assisted in filing of records and documents, control and transfer AQL waste with proper handling, perform sampling of material that was reviewed
- Review documentation associated with raw materials intermediate and finished product, prepare documentation for final disposition, audit data from Quality Control, vendors' certificates of analysis, and other relative warehouse documentation of products and clinical release.
Education
High School Diploma -
Miami Central Sr. High School
Miami, FL05.2006
No Degree - General Studies
Miami Dade College
Miami, FLSkills
- Thorough understanding of pharmaceutical operations covering all dosage forms
- Working knowledge of pharmaceutical manufacturing and associated control systems
- Thorough understanding of cGLP, cGMP, OSHA, SOP's and FDA regulations
- Working knowledge of inventory system (SAP)
- Demonstrated excellent problem-solving skills
- Effective Task-oriented team player to accomplish assigned tasks
- Highly organized, and competent
- Detail oriented, and a keen eye for detail
- Author scientific documentation
- Microsoft Windows (word, excel, power point, outlook, publisher etc)
- Laboratory safety protocols
- Sample preparation
- Microscopy techniques
- Lab result interpretation
- In-process inspection
- Internal auditing
- Customer focus
- Quality control processes
References
Available upon request
Timeline
Lab Tech Relief
Leprino Foods
12.2023 - Current
Senior Regulatory Affairs Associate
Arnet Pharmaceutical
01.2013 - 12.2023
Quality Assurance Document Control Specialist / Quality Assurance Inspector
Vital Pharmaceuticals VPX
06.2011 - 01.2013
Manufacturing Process Technician II
Watson Pharmaceutical
03.2009 - 06.2011
Quality Assurance Inspector / Manufacturing and Packaging Operator Line Lead
Schering-Plough Pharmaceutical Laboratory
09.2007 - 01.2009
High School Diploma -
Miami Central Sr. High School
No Degree - General Studies
Miami Dade College