Responsible for compilation and authoring of Annual Product Review reports for all drug products produced at Ferndale Labs. Responsible for quality system functions including: management of quality investigations, deviation reporting, and tracking of investigations, deviations and associated corrective and preventative actions (CAPA). Initial QA review of laboratory and quality related investigations and CAPA. Review of CAPA for confirmation of completion and creation of effectiveness checks. Review workflows for CAPA related document changes in the MYQUMAS system.

Compiling and reporting all QMS related data for Annual Product Review reports for all drug products manufactured at Ferndale Labs in accordance with a defined schedule
Assigns Quality Investigation (QI) numbers and tracks all quality/GMP investigations and deviations
Assists other departments with Quality Investigations and Deviation history review
Responsible for initial review of all QI & ITFI/ CAPA reports
Administers corrective and preventative action (CAPA) system
Documents completion of CAPA and where applicable assigns and completes effectiveness checks to assure CAPA effectiveness
On weekly basis provides QMS Supervisor the status of Quality Investigations and Event Notices to report in the cross-functional QI meeting
Processes and reviews workflows in the DocCompliance system for Standard Operating Procedures, specifications and forms

Requirements

A well-established knowledge of Food and Drug Administration (FDA) and cGMP requirements.

Experience in technical writing or report writing with data compilation and presentation. Experience with deviation handling, CAPA and effectiveness checks.

High degree of proficiency with both verbal and written communication skills and a proficient working knowledge of Microsoft Office suite including MS Word and Excel, with data graphing skills.

Must be self-motivated, organized, detail oriented /accurate and able to work independently to resolve problems.

Requires a Bachelors degree in a scientific discipline, or an equivalent amount of education and 5 to 7 years experience, with a minimum of three years experience in the pharmaceutical or medical device industry, with at least three years in quality (preferred Pharma QA).

*Please note, as a FDA-regulated pharmaceutical manufacturer, as well as a federal contractor- this position requires a preplacement drug screen/physical and background checks.

EO Employer M/F/Vets/Disabled

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Ferndale Laboratories, Inc.

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Quality Assurance Specialist