Senior Scientist, Quality Control

Amneal•Piscataway Township, NJ

7d•$115,000 - $120,000•Onsite

About The Position

Responsible for performing testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, and cleaning verification samples following written procedures and applicable SOPs. This role involves calculating and reporting results on applicable specification documents, participating in method transfer activities, and providing feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture. The Senior Scientist will perform physical and chemical analysis, comply with cGMps, SOPs, and STPs to avoid out-of-specification situations, and assure compliance with state and federal regulations. They will also participate in project work, process validation, cleaning validation/verification testing, and assist other scientists with analytical, instrument, and software-related problems. This role requires the use of various analytical instruments, calibration of equipment, documentation of analysis, investigation of laboratory results, and review of analytical data. The Senior Scientist will report abnormal findings to the Supervisor and assist with non-routine special projects, including out-of-specification and out-of-alert limit investigations. Additionally, they will ensure expired chemicals and reference standards are removed from the laboratory area and assist with the hands-on training of newly hired Technicians or Scientists at lower levels.

Requirements

Perform testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs.
Calculate and report results on applicable specification documents.
Participate in method transfer activities within departments or between facilities or organizations.
Provide feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture.
Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including products on stability, according to written methods, material specification, and company policies as identified in standard operating procedures (SOPs).
Comply with cGMps, SOPs, and STPs to avoid out-of-specification situation.
Assure compliance with state and federal regulations.
Actively participate in any project work as and when assigned.
Perform process validation and cleaning validation/verification testing on various drugs.
Assist other scientists with analytical, instrument and software related problems as required.
Use sonic sifter, laser diffraction, Karl Fischer, UV-Vis spectrophotometer, Infra-red spectrophotometer, HPLC with UV detection as well as with conductivity detection, TLC, pH meter, and dissolution.
Calibrate HPLC, Dissolution apparatus equipped with auto-sampler and /or in-line UV, pH meters, analytical balances, and Karl-Fischer titrator.
Document steps followed during analysis execution, calculate and report results.
Actively participate in investigation of laboratory results.
Review laboratory analysis data for completeness, specification compliance, and compliance with company’s written policies.
Report any abnormal findings to the Supervisor.
As assigned, perform in-depth review of analytical records/reports to assure that calculations and other data are technically correct and compliant to relevant specifications.
Assist the laboratory supervisor with handling non-routine special projects requiring activities such as out-of-specification investigations and out-of-alert limit investigations in the laboratory.
Ensure that expired chemicals and reference standards are removed from laboratory area.
Perform calibration of HPLC, GC, and other equipment as assigned by the supervisor.
Assist with hands-on training of newly hired Technicians or Scientists 1 and 2 levels.

Responsibilities

Perform testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, and cleaning verification samples.
Calculate and report results on applicable specification documents.
Participate in method transfer activities within departments or between facilities or organizations.
Provide feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture.
Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including products on stability, according to written methods, material specification, and company policies.
Comply with cGMps, SOPs, and STPs to avoid out-of-specification situations.
Assure compliance with state and federal regulations.
Actively participate in any project work as and when assigned.
Perform process validation and cleaning validation/verification testing on various drugs.
Assist other scientists with analytical, instrument and software related problems as required.
Use sonic sifter, laser diffraction, Karl Fischer, UV-Vis spectrophotometer, Infra-red spectrophotometer, HPLC with UV detection as well as with conductivity detection, TLC, pH meter, and dissolution.
Calibrate HPLC, Dissolution apparatus equipped with auto-sampler and /or in-line UV, pH meters, analytical balances, and Karl-Fischer titrator.
Document steps followed during analysis execution, calculate and report results.
Actively participate in investigation of laboratory results.
Review laboratory analysis data for completeness, specification compliance, and compliance with company’s written policies.
Report any abnormal findings to the Supervisor.
Perform in-depth review of analytical records/reports to assure that calculations and other data are technically correct and compliant to relevant specifications.
Assist the laboratory supervisor with handling non-routine special projects requiring activities such as out-of-specification investigations and out-of-alert limit investigations in the laboratory.
Ensure that expired chemicals and reference standards are removed from laboratory area.
Perform calibration of HPLC, GC, and other equipment as assigned by the supervisor.
Assist with hands-on training of newly hired Technicians or Scientists 1 and 2 levels.