logo

Analytical Scientist II

  • Anywhere

Company :
PL Developments

Location :
Miami, Florida

Expiry Date :
Mon, 08 Mar 2021 23:59:59 GMT

Apply Job :
Open Link

Description :
Job Details Full-timeEstimated: $49,000 – $70,000 a year2 hours ago Qualifications – FDA regulations – CGMP – Communication skills – High-performance liquid chromatography – Bachelor’s degree – Master’s degree Full Job Description Job Details Description Shift: 1st Shift Scheduled Hours: Monday thru Friday / 8:00 A.M. – 4:30 P.M. JOB QUALIFICATIONS: BS or MS in Chemistry with a minimum 3+ years of pharmaceutical experience or equivalent combination of education and experience with testing Finished Products and Raw Materials Strong technical skills in HPLC and GC required Demonstrated use of the analytical techniques in support of product development activities Comprehensive knowledge of current Good Manufacturing Practices (cGMP), FDA Guidance, and ICH Guidelines Familiar with requirements of various pharmacopeias (USP, EP, JP) and basic regulatory requirements and applies knowledge appropriately to activities Demonstrated ability to work well in a fast-paced setting. Demonstrate ability to produce and interpret laboratory results Self-starter with a strong work ethic. Must be able to operate with minimal supervision Excellent written and verbal communication skills. Problem solving skills POSITION RESPONSIBILITIES: Creates and executes new methods or procedures through appropriate research, development and validation stages with limited supervision Creates and executes project protocols and reports to support new product research and development as assigned by management with limited supervision Performs testing on raw material, in-process & finished product samples when applicable Documents all data in corresponding laboratory notebook and files documentation according to approved SOP and data integrity guidelines Supports pilot scale manufacturing to scale up of new manufacturing processes with limited supervision Responsible for analytical method validation/verification/transfer from R & D or client site to QC when assigned Interface with contract labs regarding QC sample handling and reporting Evaluate and interpret the test results and other related technical documentation Performs routine maintance and troubleshooting of analytical equipment with limited supervision Document writing will include, but not limited to, preparation and review of SOPs, STMs, failure investigation and process deviation report, stability study protocol/report, method transfer protocol/report, method validation/verification protocol/report, instrument qualification protocol/report and analytical technical transfer protocol/report with the assistance of the supervisor when assigned Other duties may be assigned as deemed appropriate by management PHYSICAL REQUIREMENTS: Employees are required to wear eye protection and lab coats while in the lab area Work safely and follow all OSHA regulations and company safety policies and procedures Ability to frequently lift and/or move up to 25 lb Ability to occasionally lift and/or move up to 35 lb Ability to regularly stand, sit and walk to perform task Qualifications Education Required Bachelors or better in Chemistry. Experience Required Technical Skills in HPLC and GC 3 years: Pharmaceutical Experience Show full job description Apply Now