Senior Quality Assurance Scientist

Senior Quality Assurance Scientist

DUTIES RESPONSIBILITITES: To assure that the manufacturing operations Parenteral and/ or Oral Solid Dosage are performed in compliance with domestic and international cGMP regulations, and policies and procedures. To provide scientific approach and Quality assurance direction to the approval of the GMP documents such as batch records, protocols, procedures, qualification and validation reports. Enforce critical analytical thinking in the investigation management process specifically during root cause analysis, risk assessment evaluation and corrective and preventive actions determination to guarantee that gaps are properly addressed. 

MINIMUM REQUIREMENTS
Bachelor Degree in Science (Chemical, Engineering, Biology, Pharmacy or Microbiology). Six (6) years of experience in Quality Assurance responsibilities in a pharmaceutical industry. Knowledge of manufacturing operations of Oral Solid Dosage and Parenteral Products Manufacturing. Strong knowledge of relevant GMP, FDA, EU regulations and the ability to interpret and apply them for intended use.  Fully bilingual (Spanish/English) communication skills, both written and verbal. Proficient knowledge of computer systems (Microsoft Office etc.) and applications like Trackwise and SAP. Solid ability for analyzing data detecting deviations, inconsistencies and interpret sampling test results. Proficient knowledge of problem solving and root cause analysis methodologies (i.e. Kepner Tregoe). Willing to work irregular hours, rotative shifts, weekends and holidays when needed.

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.

About 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 kellyservices.com 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.

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