Microbiology Data Reviewer

• AMAZING OPPORTUNITY to join a great PHARMACUTICAL TEAM working ONSITE in Raleigh, NC!!!*
• Amazing opportunity to join a growing Pharmaceutical company working as a Data Review working with their paper records and some digital. Must have a Microbiology based experience to be able to preform these duties!!!* ****MUST BE OPEN TO WORKING 2nd/3rd SHIFT!!!****
• MUST HAVE:* *
• Microbiology experience and microbiology data review needed for their process/SOP* *
• Technical Degree (BS/BA in a Scientific Discipline)* *
• 7-10 years of Pharmaceutical/GMP environmental experience* *
• Previous investigation writing and auditing experience* *
• Knowledge of cGMP, GLP and FDA requirements* *
• Paper Records Experience*
• SKILLS:* *
• Kinetic LAL and Gel-clot LAL* *
• Environmental Monitoring* *
• Filtration and Aseptic Technique* *
• Particulate Testing* *
• Investigation Writing*
• Description:*
• Will be responsible for conducting Microbiology investigations of varying degrees (environmental monitoring excursions, non-compliance with procedures, general OOS/OAL for microbiology testing and executing subsequent corrective actions as deemed necessary based on findings of investigations).
• Will also be responsible for conducting GMP/GDP data review of laboratory analyses and associated write-up documentation as well as updating of documents and procedures in coordination with Microbiology management.
• Will ensure the analysts adherence to test methods, SOPs, etc. when reviewing data, and that data integrity was maintained throughout the testing process.
• Will assist in development and execution of robust CAPAs based on outcomes of investigation will be within the scope of this position.
• Will ensure Timely initiation and closure of all investigations will be expected to ensure that compliance with internal requirements are met.
• Skills:* microbiology, data review, OOS/OAL Investigations, CAPAs, SOPs, gmp environment, data entry
• Additional Skills & Qualifications:*
• Prefer Technical / sciences based degree
• Experience with authoring Lab investigations in relation to environmental monitoring excursions, non-compliance with procedures, and general OOS/OAL investigations.
• Determining and executing corrective actions stemming from investigations
• Review of data, data entry, reporting and logbooks.
• Experience Level:* Intermediate Level
  
  

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. Were supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.