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11 days old

Senior Quality Assurance Scientist

Kelly Services
Manatí, PR 00674
**Senior 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 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. Interfaces directly with manufacturing operations to ensure that appropriate procedures are in place, through the execution of thorough reviews of procedures against practice. Leads and participates in the critical review of all documents associated with the manufacturing operations, release, packaging and relevant activities in the operations areas. Ensures that deviation on documentation dealing with OOS or process parameters outside filing or validation are investigated and resolved by thoroughly reviewing timely corrective actions. Provides key technical guidance and oversight to manufacturing operations areas (OSD and / or Parenteral product) such as Compounding, Filling, preparation, capping, Inspection, compression and packaging to assure the appropriate cGMPs are in place through weekly operations audits. Ensures compliance of all procedures (SOPs) to avoid potential regulatory and compliance issues. Provides scientific input into investigations management to assure root cause and CAPAs are aligned with the opportunities identified in order to perform a systematic approach. Supports actively the investigation process occurred in manufacturing area (OSD and Parenteral products) and warehouse, Microbiology laboratory, facilities and utilities providing coaching from Quality perspective. Manages audit observation, investigations, change control and CAPAs records in Trackwise on timely manner. Provides technical guidance and quality assurance support in the transfer of new products and process to maintain quality standards.


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 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 interestsits 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, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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 benefits ?). 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. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-05-03 Expires: 2021-06-03

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Senior Quality Assurance Scientist

Kelly Services
Manatí, PR 00674

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