Ronak Rana
Rockaway,NJ
Summary
A hardworking and dedicated employee with 14 years of diverse experience working in Manufacturing packaging, logistics, the Food Industry, and pharmaceutical health and wellness areas. Known for excellent communication skills, team player attitude, and ability to find workable solutions to challenges problems. My core competencies include compliance, quality assurance, quality control, document management, office support, and assistants.
Detail-focused Quality Auditor known for productivity and efficiency in task completion. Specialize in process optimization, compliance monitoring, and risk management, bringing valuable insights into operational improvements. Excel in communication, problem-solving, and adaptability, ensuring seamless coordination across teams to maintain high standards of quality control.
Overview
17
17
years of professional experience
Work History
Quality Auditor
NSF International
06.2024 - 11.2024
- Serve as a QA and regulatory resources department-wide within the framework of a QA and Compliance unit
- Prepare detailed deviation reports, including all findings, root cause analysis, and CAPA
- Assess the impact of the deviation on product quality, safety, and compliance
- Ensure that all deviation handling and investigation activities comply with regulatory requirements and quality standards
- Performed duties in a clean room environment including quality controls for GMP standards
- Activities of a Quality program include Development, maintenance, review, and approval of Sops Training programs, competency assessment programs validation and results record keeping, and Document control systems
- Ensure proper control of all quality-related documents, including SOPs, work instructions, and records
- Performing wash room quality control following Standard Operating Procedures and related manuals
- Conduct root cause analysis and implement corrective actions to resolve quality complaints and prevent recurrence
QA Operation Supervisor / Documents Specialist
QUTEN Research Inc
Pine Brook, NJ
08.2022 - 06.2024
- Describe the Product and Specify its Contents
- Identification of the Product or Brand
- Grading the Product with Quality agreements, ECAR & CCRs (Continuous Curriculum Review), Deviation & CAPA
- Helped release products, including the design of artwork and labels
- Providing information required by Law:
- Gather all relevant data and information needed to conduct a comprehensive investigation
- Root cause corrective action (RCCA)
- Conduct routine analysis using validated methods to ensure consistent product quality
- Develop and implement CAPA plans to address root causes identified during investigations
- Experience with label approving of all the product
- Corrective action involves
- Oversee the creation, review, approval, and distribution of quality-related documents within Veeva Vault, such as SOPs, batch records, and validation protocols
- Identify quality problems and recommend solutions
- Monitor testing procedures to ensure that
- Train other analysts to perform
- Conduct thorough investigations to identify the root cause of customer complaints
- Identify and troubleshoot equipment problems
Certified Quality System Quality Control and Assurance Specialist
UNIFIRST/UNICLEAN CLEANROOM SERVICE
Maplewood, NJ
01.2022 - 08.2022
- Responsible for ensuring timely and effective implementation of all company's policies and procedures
- Activities involved in assuring the quality of manufactured products
- Develop, review, and update SOPs related to investigations to ensure consistency and compliance
- Prepare detailed investigation reports, including findings, root cause analysis, and recommended corrective actions
- Ensure that all quality processes and documentation are in compliance with regulatory standards (e.g., ISO 9001, GMP)
- Conducting regular audits of production lines or departments to ensure compliance with the company standards
- Monitor employee attendance and take disciplinary action if necessary
- Develop and implement CAPA in response to complaint investigations
- Conduct a thorough investigation to identify the root cause of the complaint
QA shop floor Supervisor
MONDELEZ INTERNATIONAL INC.
Fairlawn, NJ
01.2016 - 12.2021
- Company Overview: One of the world's largest snack companies with global iconic brands, including Oreos, Teddy Grahams, And Lorna Doune cookies
- Promoted to Production Line Supervisor / Quality Analyst
- Ensuring food safety requirements and plant safety practices
- Complete the process of Cleaning six food production lines bi-weekly in an efficient manner according to 5S standards
- Develop and manage inspection plans and quality control procedures within SAP to ensure products meet quality standards
- Ensure the combination product meets all regulatory requirements from agencies such as the FDA, EMA, etc
- Conduct comprehensive testing on finished combination products to ensure they meet all quality standards and regulatory requirements
- Ensure that all investigation activities comply with relevant regulatory requirements and standards such as FDA and ISO
- Follow all instructions and requirements from the Manager as dictated by Good Manufacturing Practice, including (GMP) and Standard Operating Procedure
- One of the world's largest snack companies with global iconic brands, including Oreos, Teddy Grahams, And Lorna Doune cookies
Quality Control Inspector
PREMIER BRANDS OF AMERICA
Mount Vernon, NY
01.2014 - 11.2015
- Responsible for identifying quality problems and recommending solutions
- Ensure QMS documentation is up-to-date and accessible
- Monitor testing procedures to ensure that all the tests are performed according to established items
- Check the quality of incoming and outgoing materials or products for a company
Certified IV Specialist/Pharmacy Lead
WHITE PLAINS MEDICAL CENTER
White Plains, NY
01.2008 - 01.2013
- Prepared antibiotics, IVs, and refills on the PYXIX medication machine
- Managed robotic medication machines in Orthopedics, ICU, NICU, CCR, and ER Departments
- Performed basic repairs and maintenance on the PYXIS medication machine
- Acted as a trainer to all new pharmacy interns and 20 new employees over a year tenure
Education
Bachelor's degree - Business Management
M.S. University
India01.2005
High School Diploma -
Zenith High School
India01.2001
Skills
- Good Manufacturing Practice (GMP)
- Health and Safety Standards
- Problem Solver
- Inventory Management
- CAPA
- Deviation
- Root Cause
- Write a Specifications, SOP
- Change Control
- Client Complaints
- Investigation
- Expertise in MS Office
- Excel sheet
- PowerPoint
- Inspection
- Audit (FDA/NSF)
- SAP
- Batch Records
- Combination Products
- ISO 9001
- Product auditing
- Investigation leadership
- Safety monitoring
Keyaccomplishments
- Employee of the Year Award, 12/2012, Recognized by colleagues and managers for excellent performance and meticulous attention to detail in all plant areas.
- Perfect Attendance Award, 12/2020, Received for 16 consecutive quarters over the past four years.
- Excellent Pharmacy Employee Distinction, 12/2010
Timeline
Quality Auditor
NSF International
06.2024 - 11.2024
QA Operation Supervisor / Documents Specialist
QUTEN Research Inc
08.2022 - 06.2024
Certified Quality System Quality Control and Assurance Specialist
UNIFIRST/UNICLEAN CLEANROOM SERVICE
01.2022 - 08.2022
QA shop floor Supervisor
MONDELEZ INTERNATIONAL INC.
01.2016 - 12.2021
Quality Control Inspector
PREMIER BRANDS OF AMERICA
01.2014 - 11.2015
Certified IV Specialist/Pharmacy Lead
WHITE PLAINS MEDICAL CENTER
01.2008 - 01.2013
Bachelor's degree - Business Management
M.S. University
High School Diploma -
Zenith High School