Sr Quality Assurance Scientist

To assure that the manufacturing operations (Parenteral and/ or Oral Solid Dosage) are performed in compliance with domestic and international cGMP regulations, and Customer 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, 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®?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity.

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