Description
Do you have batch record review experience in the biotech/pharmaceutical industry? Are you confident in your understanding of cGMP? Do you have excellent investigational and analytical skills? Are you ready to take on one year contract with a famous biotechnology company inMassachusetts? If your answer is yes, keep reading!DUTIES:
As a lot review associate, you must assert the highest level of professionalism and proficiency while thinking critically to solve problems. You must demonstrate outstanding interpersonal skills as well as excellent communication skills in both verbal and written formats. The associate will need to be able to work both independently as well as integrate successfully into a team, as well as deliver under pressure.
-Perform review of QC reports, action limit excursions, and assay variances
-Investigation review to batch history records
-Management of batch record activities
-Oversight and assurance that products are manufactured before deadlines and are in compliance with regulatory requirements and company policies
-Maintain relationships with relevant departments and Senior Management teams
-Solve complex problems through application of advanced theory and cross-functional expertise
REQUIREMENTS
BS/BA with experience in life sciences pharmaceutical/biotech industry
3-6 years pharmaceutical experience in QA/QC and manufacturing
-At least 1 year of batch/lot review experience in filling or biochemical operations
-GMP expertise and knowledge ofU.S.and international Regulatory agencies
-Fluency in French of German is a plus
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To find out more about Real please visit www.realstaffing.com