Analytical Data Reviewer FL

Job DescriptionJOB QUALIFICATIONS:Bachelor’s degree in chemistry or related field5+ years Pharmaceutical analytical data review experience preferredSolid knowledge of cGMP, GLP, GDP concepts Federal RegulationsPrevious experience conducting Analytical data reviewWorking knowledge of cGXP, Data integrity, ALCOA principlesReview of standard testing procedures (STM), general procedures, excipients COAs, packaging components COAsOperational understanding of laboratory equipment and pertinent software (Empower/LIMS)Critical thinking, problem solving, and analytical thinking applied to data and diverse situationsExcellent interpersonal communication skills: verbal and written skillsAble to work multiple priorities in parallelComputer proficiency: Word, Excel, and Power PointPosition Responsibilities:Final review of analytical data including, but not limited to raw materials, finish products, and stability data including method validation/ verificationsEnsures that analytical data is in compliance with GMP, GLP, and GDPManage routine minor corrections with the Lab ChemistCommunicates any Out of Specification (OOS) or Out of Trend results (OOT) identified during data review to the QC Manager or Quality DirectorInforms the QC Manager or Quality Director of any critical data integrity issues or data irregularitySupport other tasks that might be oriented by the QC Manger or Quality DirectorPhysical Requirements:Adhere to all safety policies; includes wearing personal protective equipment when requiredAbility to work standing/walking 50% of the timeAbility to occasionally: lift 10-50lbs, carry 10-50lbs and to stand, bend and stoopCompany DescriptionPL Developments is an over-the-counter pharmaceutical manufacturing and packaging company, headquartered in New York. We have an excellent work environment, truly invest in our people, and believe in great work/life balance. We offer a comprehensive benefits package.PLD participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.PL Developments is an over-the-counter pharmaceutical manufacturing and packaging company, headquartered in New York. We have an excellent work environment, truly invest in our people, and believe in great work/life balance. We offer a comprehensive benefits package. PLD participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.