QA CHEMIST

QA CHEMIST is needed to perform the following duties:

• Scientifically analyze raw materials, in-process & finished product samples, process validation samples and water samples as per established procedures under close supervision of senior chemists/scientists.
• Conduct internal audits in a group setting & under guidance from senior chemists/scientists for compliance with SOP, cGMP & FDA requirements.
• Assist in drafting SOP’s by researching new regulatory guidance and cGMP and by preparing reports for senior chemists/scientists and department heads to review.
• Conduct initial review of IQ, OQ, PQ and QC/manufacturing documents.
• Monitor process validation activities in a group setting by collecting samples, performing laboratory analysis/tests under supervision and prepare scientific reports for senior chemists/scientists to review.
• Work with advanced equipment such as HPLC and GC systems, UV-visible spectrophotometer etc.
• Perform a wide variety of inspections, checks, tests and sampling procedures for the manufacturing process while working as part of a group of chemists/scientists under close guidance/supervision from experienced chemists/scientists.
• Review scientific data from manufacturing operations and prepare drafts of batch manufacturing and packaging records for review & approval by experienced chemists/scientists.
• Calibrate/check critical laboratory equipment and instrumentation and assist in drafting/updating inspection procedures and checklists as necessary.
• Review and analyze (chemical analysis & tests) any departure from established procedures and investigate any product failures under guidance of experienced chemists/scientists.
• Approximately 85% of the time will be spent in scientifically analyzing raw materials, in-process and finished product samples, validating results, conducting internal audits and implementing SOP’s under close supervision and guidance of experienced chemists/scientists in our Quality Assurance team.
• Approximately 15% of the time will involve preparing reports, documents and papers and conferring/interacting with scientists and maintaining ICH guidelines and US FDA regulations.

• Bachelor’s degree is required in Chemistry or Environmental Science.