Scientist III at Jobot
Lynwood, CA 90262
About the Job
Up to 95K base salary + Excellent Benefits - Room for Growth - Leading Manufacturer in the pharma industry
This Jobot Job is hosted by: Gabriel Ozuna
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $85,000 - $95,000 per year
A bit about us:
We are a leading manufacturer and distributor of over the counter pharmaceutical and consumer healthcare products with a commitment to improving peoples lives every day.
Why join us?
Job Details
POSITION RESPONSIBILITIES:
The Ability to analyze Finish Good Products and Raw Materials on HPLC, GC, FTIR, and Titrations (visual and potentiometric).
Ability to manage multiple projects and accurately project realistic timelines.
Ability to Qualify Raw Materials by compendial testing procedures.
Authors Analytical Method Validation or Method Verification Protocols as guided by ICH, FDA, and cUSP.
Responsible for analytical method validation/verification/transfer from clients or R&D to QC when assigned.
Performs testing on raw material, in-process, & finished good samples when applicable.
Documents all data in corresponding laboratory notebook and files documentation according to approved SOP and data integrity guidelines.
Interface with contract labs regarding QC sample handling and reporting.
Evaluate and interpret the test results and other related technical documentation.
Additional document writing includes, but not limited to, preparation and review of SOPs, STMs, failure investigation and process deviation report, stability study protocol/report, instrument qualification protocol/report and analytical technical transfer protocol/report.
Other duties may be assigned as deemed appropriate by management.
Mentors QC chemists and assists with training and professional development.
Upholds all elements of data integrity.
JOB QUALIFICATIONS:
BS/MS in Chemistry or related Scientific Discipline with a minimum of 8 years of pharmaceutical experience or equivalent combination of education and experience with testing Finished Products, Raw Materials, and Analytical Method Verification, Validations and Transfers.
Advanced technical skills in HPLC and GC required, including theoretical understanding of technique, troubleshooting, maintenance and consumable replacements.
Advanced level of Chromatography Data Software (CDS) preferably Empower 3.
Ability to enable quantification for assays and impurities calculations, create custom calculations, and design chromatographic reports in CDS.
Able to interpret data, including evaluation of stability testing for trends.
Demonstrated use of analytical techniques in support of product development activities.
Comprehensive knowledge of current Good Manufacturing Practices (cGMP), regulatory requirements, and ICH Guidelines
Understanding and adherence with CFR 21 Part 11 requirements.
Understanding, Knowledge, and performing of Raw Material qualifications of new incoming raw materials along with annual review requirements for existing Raw Materials.
Comprehension and ability to follow procedures of various pharmacopeias (USP, EP, JP).
Comprehension of regulated guidance (WHO, FCC, FDA, and ICH)
Understanding and basic regulatory requirements and applies knowledge appropriately to activities.
Demonstrated ability to work well in a fast-paced setting with teams.
Self-starter with a strong work ethic.
Must possess problem solving skills.
Must be able to operate with minimal supervision.
Demonstrated ability to train and/or mentor employees.
Excellent written and verbal communication skills.
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
This Jobot Job is hosted by: Gabriel Ozuna
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $85,000 - $95,000 per year
A bit about us:
We are a leading manufacturer and distributor of over the counter pharmaceutical and consumer healthcare products with a commitment to improving peoples lives every day.
Why join us?
- We value our employees and we foster an environment where people are passionate about their work.
- Competitive Pay
- Excellent Benefits
- Stable organization with a national presence
Job Details
POSITION RESPONSIBILITIES:
The Ability to analyze Finish Good Products and Raw Materials on HPLC, GC, FTIR, and Titrations (visual and potentiometric).
Ability to manage multiple projects and accurately project realistic timelines.
Ability to Qualify Raw Materials by compendial testing procedures.
Authors Analytical Method Validation or Method Verification Protocols as guided by ICH, FDA, and cUSP.
Responsible for analytical method validation/verification/transfer from clients or R&D to QC when assigned.
Performs testing on raw material, in-process, & finished good samples when applicable.
Documents all data in corresponding laboratory notebook and files documentation according to approved SOP and data integrity guidelines.
Interface with contract labs regarding QC sample handling and reporting.
Evaluate and interpret the test results and other related technical documentation.
Additional document writing includes, but not limited to, preparation and review of SOPs, STMs, failure investigation and process deviation report, stability study protocol/report, instrument qualification protocol/report and analytical technical transfer protocol/report.
Other duties may be assigned as deemed appropriate by management.
Mentors QC chemists and assists with training and professional development.
Upholds all elements of data integrity.
JOB QUALIFICATIONS:
BS/MS in Chemistry or related Scientific Discipline with a minimum of 8 years of pharmaceutical experience or equivalent combination of education and experience with testing Finished Products, Raw Materials, and Analytical Method Verification, Validations and Transfers.
Advanced technical skills in HPLC and GC required, including theoretical understanding of technique, troubleshooting, maintenance and consumable replacements.
Advanced level of Chromatography Data Software (CDS) preferably Empower 3.
Ability to enable quantification for assays and impurities calculations, create custom calculations, and design chromatographic reports in CDS.
Able to interpret data, including evaluation of stability testing for trends.
Demonstrated use of analytical techniques in support of product development activities.
Comprehensive knowledge of current Good Manufacturing Practices (cGMP), regulatory requirements, and ICH Guidelines
Understanding and adherence with CFR 21 Part 11 requirements.
Understanding, Knowledge, and performing of Raw Material qualifications of new incoming raw materials along with annual review requirements for existing Raw Materials.
Comprehension and ability to follow procedures of various pharmacopeias (USP, EP, JP).
Comprehension of regulated guidance (WHO, FCC, FDA, and ICH)
Understanding and basic regulatory requirements and applies knowledge appropriately to activities.
Demonstrated ability to work well in a fast-paced setting with teams.
Self-starter with a strong work ethic.
Must possess problem solving skills.
Must be able to operate with minimal supervision.
Demonstrated ability to train and/or mentor employees.
Excellent written and verbal communication skills.
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
Salary
85,000 - 95,000 /year