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Quality Assurance Specialist

Company: Kelly Scientific Resources
Location: Largo
Posted on: February 2, 2019

Job Description:

QA Technical Assurance Specialist- Largo, FLKelly Scientific is seeking an experienced QA Specialist with experience with CAPA's, Deviations and OOS Investigations for a pharmaceutical manufacturing organization in the Largo, FL area. This is a direct hire opportunity. Monday - Friday on the 1st shift.Job Summary:The QA Technical Assurance Specialist ensures compliance by authoring and/or reviewing the appropriateexecution of Quality Assurance related documents including: Deviations, OOS investigations, CAPA andChange Controls. The incumbent, will also be responsible for reviewing other technical documents in supportof Operations, Quality Assurance, Quality Control, validation and equipment qualification activities. Alsoresponsible for working with company subject matter experts to write and edit technical documentation whileensuring compliance with applicable regulatory requirements.Job Responsibilities:--- Review and approval of technical documents including: SOPs, validation and qualification documents(IQ/OQ/PQ/PPQ), specifications and change requests for facility, manufacturing, and laboratory.--- Primary contact for all Notice of Events (NOEs). Assess and classify NOE and ensure prompt initialproduct impact and scope.--- Primary quality contact for customer complaints/ notifications.--- Write investigations and gather information from internal and external sources in order to evaluate theimpact of the occurrence, risk to future processes, root cause analysis, CAPA determination andeffectiveness.--- Partner with subject matter experts to conduct investigations--- Ensure proper root cause analysis using various investigative techniques.--- Ensure each investigation is closed within the 30-day time frame and ensure extensions are filed asappropriate.--- Works cross-functionally in identifying appropriate corrective/preventative actions designed to mitigatequality deficiencies.--- Oversee the CAPA (corrective and preventative action) system and ensure timely closure and extension(if warranted).--- Develop, implement and monitor the CAPA effectiveness system.--- Develop and implement tracking mechanisms for investigations, CAPAs and other documents. Reportmetrics to Quality Council.--- Escalate potential quality issues to Sr. Management as appropriate.--Qualification and Requirements:A Bachelor's Degree is required. A focus degree in Science or Engineering is preferred. 4+ years ofpharmaceutical/FDA regulated facility or other GMP regulated environment.Individual must demonstrate the following:--- Ability to read, analyze and interpret common scientific and technical documents.--- Strong written and verbal communication skills. A technical writing background is preferred.--- Proven investigational skills including prior experience using root cause analysis tools.--- Strong decision-making/analysis skills, problem-solving and Lean mindset.--- Thorough understanding of compliance requirements and ability to follow detailed written procedures.--- Ability to handle multiple, at times complex tasks and prioritize and adapt to business needs.--- Proficient in Microsoft Office Suite of programs (Word and Excel is required, Visio, Project, PowerPoint, andAccess skills are preferred).--- As part of your job duties, travel between office buildings is required on a routine basis.Reporting Structure and Supervisory Responsibilities--- Reports to Quality Assurance Supervisor--Benefits & Compensation:This position offers a competitive total compensation package, including health benefits (medical, dental, andvision), 401k with company match, life insurance, and paid vacation and personal time.

Why Kelly--?
With Kelly, you'll have access to some of the world's highest-regarded scientific organizations-

providing you with opportunities to work on today's most challenging, research-intensive, and relevant

projects. Our connections can lead you to innovative scientific pursuits you'll be proud to help

advance. We work with 95 of the Fortune 100--- companies, and found opportunities for more than 9,000

scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world

a better place. Let Kelly fuel your career-connect with us today.

Kelly Services--

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect

with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,

Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is

committed to employing a diverse workforce. Equal Employment Opportunity

is The Law.

Keywords: Kelly Scientific Resources, Largo , Quality Assurance Specialist, Other , Largo, Florida

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