Anitha Eapen
Shakopee,MN
Summary
Versatile and accomplished professional with extensive experience as a Pharmacist, Clinical Research Coordinator, and currently working as a Medical Device Quality Control Inspector. Proven ability to provide high-quality patient care, manage complex research studies, and ensure product quality through inspections and data analysis. Exceptional communication and interpersonal skills with a commitment to cross-functional teams, and ensuring compliance with regulatory requirements. Dedicated to continuous learning and professional development to stay current with industry trends and advancements.
Familiar with US FDA Medical Device Regulations, FDA 21 CFR Part 820/211, Medical Device Process Validation, IS0 13458, ISO 9001.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Medical Device Quality Control Inspector
STERIS, Key Surgicals
11.2022 - Current
- To ensure safety, effectiveness, and compliance of medical devices within a manufacturing or production environment.
- The primary responsibility of this role is to inspect and evaluate medical devices, components, and processes to ensure they meet established quality standards, regulatory requirements, and specifications.
- Closely with production teams, engineers, and quality assurance professionals to maintain and improve the quality of medical devices.
- Followed safety protocols while handling hazardous materials.
- Provided feedback to the production team regarding product quality.
- Utilized quality control software to track and analyze product data.
- Investigated customer complaints to take necessary corrective actions.
Clinical Research Internship
Synexus Clinical Research
12.2019 - 12.2019
- Provided clinical support for projects according to Standard Operating Procedures, ICH Guidelines, and GCP
- Data collection and management, collection of source documents, using and developing CRFs, registration, and management of AEs, filing and archiving, managing monitoring visits, dealing with queries
- Maintained and organized clinical study documents including but not limited to 1572s, CVs, and IRB-IEC documents such as approvals, renewals, membership list, and other study agreements.
- Processed, tracked, and shipped specimens for testing; data entry of eCRFs and lab results in EDC and proprietary database
- Performed documents review, query generation and resolution against established data review guidelines, under direct supervision of Synexus or client data management systems
Authorization Specialist
Coram Healthcare
03.2019 - 04.2019
- Worked as Authorization specialist
- Worked closely with patient Intake coordinators and Insurance providers to verified coverage for in-home IV therapy for Coram patients.
- Verified benefit coverage and requesting authorization for payment with various Insurance companies.
- Maintained Insurance authorization for current patients.
- Re-verified Insurance coverage for changes in medication orders.
- Researched and followed up on authorization denials.
- Worked closely with branch staff to collected additional information on physician orders.
- Scanned and upload documents from Insurance providers into electronic records system and notify appropriate departments.
- Submitted changes to patient prescriptions in the system and obtained authorization for payment.
Pharmacy Technician Review Analyst
Prime Therapeutics LLC
11.2017 - 01.2018
- Developed and implemented prior authorization work flow, policies and procedures.
- Obtained all necessary information, including documents and orders on behalf of patients.
- Applied coding principles in sync with government policies and standards.
- Verified patients’ benefits and ensured that proper prior authorization and re-authorization was obtained for additional treatment.
- Assisted in verifying requests for pre-authorization.
- Looked through insurance plans in detailed manner.
- Secured patients, demographics and medical information by using great discretion and ensured that all procedures were in sync with HIPPA compliance and regulation.
Trainee Pharmacist
Al-Hasher Pharmacy
04.2014 - 11.2014
- Performed Prescription Analysis.
- Checked pharmaceutical stock for assessing inventory level, placing orders and removing outdated drugs.
- Provided basic testing services e.g., blood pressure and diabetes.
- Provided information to patients about medications and their use.
- Prepared and checked medication.
- Offered recommendations to customers on over-the-counter medications for common ailments.
- Communicated with patients to collect information about prescriptions and medical conditions or arrange consultations with pharmacists.
- Assisted pharmacist in final review of filled prescriptions.
- Communicated closely with patients, ensuring medical information was kept private.
Education
Clinical Reasearch - Clinical Research Coordinator
Clinical Research Fastrack
Atlanta, GA01.2020
Master of Pharmacy - Pharmacy
Tamil Nadu Dr. M.G.R Medical University
Chennai08.2012
Bachelor of Pharmacy - Pharmacy
Tamil Nadu Dr.M.G.R Medical University
Chennai09.2009
Skills
- Familiar with US FDA Medical Device Regulations, FDA 21 CFR Part 820/211, Medical Device Process Validation, IS0 13458, ISO 9001
- FDA Drug Manufacturing regulations 21 CFR Part 314, 21 CFR Part 210, 21 CFR Part 211, 21 CFR Part 212
- Medical Terminology
- Research Skills
- Pharmacological drug classification
- Pharmaceutical storage awareness, creativity and problem-solving skills
- Exceptional patient care and interaction
- Patient counseling
Certification
- Medical Device Regulation (MDR), (UDEMY)
- Certified Clinical Research Coordinator (Clinical Research Fastrack)
- ICH GCP Certification (NIDA)
- Certified Dangerous Goods Training (Mayo Clinic Laboratories)
- Basic Good Manufacturing Practices (GMP) (UDEMY)
- The Pharmaceutical R&D process in healthcare (UDEMY)
Timeline
Medical Device Quality Control Inspector
STERIS, Key Surgicals
11.2022 - Current
Clinical Research Internship
Synexus Clinical Research
12.2019 - 12.2019
Authorization Specialist
Coram Healthcare
03.2019 - 04.2019
Pharmacy Technician Review Analyst
Prime Therapeutics LLC
11.2017 - 01.2018
Trainee Pharmacist
Al-Hasher Pharmacy
04.2014 - 11.2014
Clinical Reasearch - Clinical Research Coordinator
Clinical Research Fastrack
Master of Pharmacy - Pharmacy
Tamil Nadu Dr. M.G.R Medical University
Bachelor of Pharmacy - Pharmacy
Tamil Nadu Dr.M.G.R Medical University