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| Employer Name: ScieGen Pharmaceuticals, Inc |
SpiderID: 13809430 |
| Location: HAUPPAUGE, New York |
Date Posted: 8/8/2024 |
| Wage: |
Category: Medical/Health |
| Job Code: |
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Job Description:
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 establish 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 sr. 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 Organic Chemistry
Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required: Bachelors
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: ScieGen Pharmaceuticals, Inc |
Company Type: |
| Company: ScieGen Pharmaceuticals, Inc |
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| City: HAUPPAUGE |
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| State: New York |
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| Zip: |
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