Anna Feldman

San Diego, CA, *****

Phone: 858-***-**** E-mail: acymom@r.postjobfree.com

SUMMARY

Organized and goal-oriented individual with five years of Quality Assurance and Document Control experience in the biotechnology industry. Skilled in document management, reviewing ELISA validation and clinical project data, specimen accessioning, medical device complaint management, and providing quality customer service to internal and external customers.

SKILLS

Knowledge of ISO 13485 and QSR 21 CFR 820.

Strong multi-tasking and prioritization skills.

Knowledge of GMP, GLP, ISO and FDA regulations.

Strong communication and interpersonal skills.

Knowledge of Electronic Document Management Systems.

Implemented Process Improvements within QA Department.

Proficient in Microsoft Word, Excel, Powerpoint, Outlook, Access, Master Control, and Watson LIMS.

Strong critical thinking and problem-solving skills.

PROFESSIONAL EXPERIENCE

INTERTEK PHARMACEUTICAL SERVICES (AEROTEK SCIENTIFIC) SAN DIEGO, CA

Quality Assurance Associate July 2016-December 2016

Represented and interacted with multiple departments to provide GLP guidance in an effective manner.

Reviewed Clinical Protocols and Study Procedures for compliance to Bioanalytical Procedures.

Reviewed clinical validation and project data for compliance to SOPs and Bioanalytical Procedures.

Determined that no deviations from approved protocols/plans or Standard Operating Procedures were made without prior authorization and documentation.

Submitted to Study Director and/or Study Facility Management periodic written inspection reports of each study, noting any problems or corrective actions taken.

Assisted with developing, revising, and reviewing SOPs. Perform SOP revision training, when necessary.

Performed study phase (In-process) inspections to ensure compliance and integrity of the clinical study.

Maintained training records of all employees.

Performed facility inspections to ensure laboratory maintained compliance to all company SOPs.

Quality Control Compliance Associate January 2016 - July 2016

Reviewed project, administrative, and any other miscellaneous notebooks for accuracy, completeness, and compliance with SOPs and Bioanalytical Procedures (BPs).

Reviewed sample receipt packets for accuracy, completeness, and compliance with SOPs, BPs, and the protocol.

Reviewed electronic data tables using Excel's VLOOKUP formulas and/or data within a LIM System for accuracy, consistency, and compliance with SOPs and BPs.

Reviewed transfer files for accuracy and compliance with the Data Transfer Agreement (DTA) or Data Transfer Specifications (DTS).

Reviewed Bioanalytical Reports for accuracy, consistency, and compliance with Intertek and client SOPs.

Become familiar with company SOPs, FDA, OECD, and other appropriate guidelines and regulations.

Assisted with developing, revising, and reviewing SOPs and QCC work instructions.

ALERE SAN DIEGO, INC (BIOPHASE SOLUTIONS, INC) SAN DIEGO, CA

Document Control Analyst November 2014 – December 2015

Logged review activities, maintained review status utilizing Microsoft Access database, and provided status update reports as requested.

Processed Engineering Change Orders within Master Control, as part of the Change Management Process

Received, classified, scanned, filed, audited, and archived Quality System documents accordingly in centralized record archival system.

Tracked the change process through development, approval, and implementation and compiled data for the creation of metrics and reports for change control activities.

Evaluated problems where analysis of situation's required evaluation of identifiable factors.

Assisted in the documentation of key processes and departmental procedures.

Researched documentation in the Electronic Document Management system (EDMS), Master Control.

TANDEM DIABETES CARE, INC (QUALSTAFF RESOURCES, INC) SAN DIEGO, CA

Insurance Verification Specialist, Pump February 2014-July 2014

Verified insurance benefits to determine cost share amounts for prospective customer responsibility.

Answered phone inquiries on a dedicated order queue.

Supported customers by providing them with order status updates and answering questions on the product and company

Collected any updated customer and insurance information.

Coordinated shipments of products to customers.

Worked with reimbursement department to ensure data provided meets invoicing requirements.

Worked as part of a support team, including members of the Field Sales team, to ensure proactive communication of prospective customer’s order status.

Quality Assurance Compliance Administrative Assistant September 2013 - February 2014

Reviewed complaints and classified issues by complaint criteria.

Assisted in trending complaint data and notified management of emerging events.

Determined complaint reportability (MDR) to FDA and other regulatory agencies.

Maintained and supported the analysis of complaint logs to help in identification of recurring issues to quality assurance management.

Notified customers of failure investigation status of their Insulin Pump and supplies.

Used and maintained database(s) or logs, provided analyses and trending on complaints.

Supported the filing of regulatory reports with the assistance of the Complaint Management team.

Provided basic technical expertise and assisted in handling complaints to comply with current FDA and International reporting regulations.

MILLENNIUM LABORATORIES SAN DIEGO, CA

Data Entry Professional November 2012-February 2013

Performed high volumes of supporting documents accurately for medical testing into a LIMS system.

Validated information received on supporting requisition forms.

Collaborated with other departments in order to resolve any discrepancies made on the patient requisition forms.

Used Microsoft Outlook for e-mail correspondence within the data entry department and also scheduled meetings with colleagues and higher management.

Complied with all clinical laboratory procedures and HIPAA regulations.

SAN DIEGO GAMMA KNIFE CENTER SAN DIEGO, CA

Medical Archivist March 2011 - October 2012

Collected, organized, and preserved patient information

Created and maintained accessible, retrievable computer archives and databases, incorporating current advances in electronic information storage technology.

Maintained patient confidentiality in accordance with HIPAA regulations.

Assisted in creating patient charts and verifying health insurance for the patient's Gamma Knife treatment plan.

EDUCATION

NATIONAL UNIVERSITY, SAN DIEGO SAN DIEGO, CA

Masters in Public Health, Health Promotion Specialization April 2011

UNIVERSITY OF CALIFORNIA, SAN DIEGO LA JOLLA, CA

Bachelors in Pharmacological Chemistry January 2007

Minor in Psychology

SAN DIEGO MESA COLLEGE, SAN DIEGO SAN DIEGO, CA

Associates in Transfer Studies (Chemistry) September 2003

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