Shivani Bhatia
@shivanibhatia
Detail-oriented QA professional with strong regulatory knowledge.
What I'm looking for
I am a well-organized QA professional with extensive experience in regulatory compliance and quality assurance. My background includes a Master's degree in Biotechnology and certifications in HACCP and ISO 9001:2015, which have equipped me with the necessary skills to excel in quality control and assurance roles.
Throughout my career, I have demonstrated my ability to manage and maintain Standard Operating Procedures (SOPs) while investigating product non-conformances and implementing corrective and preventive actions (CAPA). My role at Pure Extracts Manufacturing Corp. involved reviewing critical documents and reports related to various regulatory acts, ensuring compliance, and conducting thorough investigations into product complaints. I take pride in my analytical and problem-solving skills, which have contributed to continuous quality improvement initiatives.
In previous positions, I have successfully trained QA teams, overseen technical reviews of documents, and ensured adherence to safety and quality programs. My commitment to maintaining high standards of quality and safety has been a driving force in my career, and I am eager to bring this dedication to a new opportunity.
Experience
Work history, roles, and key accomplishments
Customer Service Coordinator
HSE Grp
May 2017 - Apr 2024 (6 years 11 months)
Coordinated between operations and technical departments, handled client accounts, and ensured customer satisfaction through effective conflict resolution.
Quality Assurance Associate
Pure Extracts Manufacturing Corp.
Apr 2020 - Sep 2023 (3 years 5 months)
Managed quality assurance processes, reviewed regulatory documents, and investigated product non-conformances. Maintained SOPs and ensured compliance with FDA and other regulations while conducting quality control checks on raw materials and finished products.
Quality Assurance Associate
WMMC
Feb 2019 - Apr 2020 (1 year 2 months)
Provided technical services in production and packaging, supported quality improvement initiatives, and maintained SOPs. Conducted critical reviews of documents and test results, and trained QA team members.
Quality Assurance Associate
Stericycle
Sep 2018 - Jan 2019 (4 months)
Ensured compliance with company policies and government regulations while managing operations. Responded to client inquiries and maintained SOPs and quality manuals.
Education
Degrees, certifications, and relevant coursework
ISO Certification Program
Certification, Quality Management
2025 - 2025
Obtained ISO 9001-2015 Certification, indicating proficiency in quality management systems.
HACCP Certification Program
Certification, Food Safety
2025 - 2025
Achieved HACCP Certification, demonstrating knowledge in Hazard Analysis and Critical Control Points for food safety.
University in India
Master's Degree, Biotechnology
2005 - 2007
Completed a Master's degree in Biotechnology, focusing on advanced biological processes and technologies.
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
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