Company : Actalent
Country: United States
Location : Indianapolis, Indiana
Post: Sun, 19 Sep 2021 05:28:18 GMT
Expires: Tue, 19 Oct 2021 23:59:59 GMT
Apply Job : Apply Online
—————————— Job Description ——————————
DESCRIPTION:Actalent is hiring for a Qualified Scientist is responsible for the technical review of results and data from in-process samples, finish product samples, raw material samples, stability samples, and environmental samples from mainly the microbiology lab and chemistry lab. Outside of reviewing and compiling data from those labs, this candidate will be responsible to compare those results against the appropriate SOPs, method validations and verifications, and GMP/FDA/Regulatory regulations. This role has NO testing responsibilities. They will also help train some of the junior lab analysts on instrumentation and documentation methods. TYPICAL DOCUMENTATION THIS CANDIDATE WILL BE RESPONSIBLE FOR:- Updating Test methods- Revising SOPs- Data Trends, Nonconformance reports- Contributing data to “out of spec” investigations (not writing whole report)- Review audit trails for data integrity requirements.- Provide technical support for laboratory investigations and review investigation reports for accuracy and completeness.- Review incoming data and contract laboratory Certificates of Analysis, if applicable.- Review chromatograms and integrations of chromatograms against method validations/verifications and/or compendial requirements for all chromatography methods.- Review all raw data and test documentation and ensure data outputs (e.g. calculations) are correct and reported per the approved method.- Provide Certificates of Analysis for test packets (finished product, raw material, special test requests, etc.).TOP SKILLS DETAILS:hplc, quality control, gmp, data review, chromatographyADDITIONAL SKILLS & QUALIFICATIONS:MUST HAVE:- Bachelor’s Degree in a life science; Chemistry preferred- 5+ years of total relevant experience — combination of experience in a lab testing role and a documentation/data reviewer role- 2+ years of lab testing experience utilizing a combination of HPLC or other chromatography methods, Uv-vis spectrophotometry, FTIR spectrophotometry – Experience reviewing lab documentsNICE TO HAVE:- Microbiology lab testing or reviewing experience- LIMS experienceEXPERIENCE LEVEL:Intermediate LevelWE HAVE INTERVIEW TIMES NEXT WEEK ONLY; AND TIMES ARE FILLING QUICKLY. IF YOU OR ANY FRIENDS/FAMILY ARE INTERESTED IN MORE DETAILS ABOUT THIS CAREER OPPORTUNITIES, APPLY TODAY OR REACH OUT TO ME DIRECTLY AS SOON AS POSSIBLE! 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.
To apply for this job please visit www.resume-library.com.