Bora Pharmaceuticals
Analyst I, QC Analytical-2nd Shift
Bora Pharmaceuticals, Baltimore, Maryland, United States, 21276
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Analyst I, QC Analytical-2nd Shift
role at
Bora Pharmaceuticals
I. JOB SUMMARY Perform analytical testing per cGMP in support of raw material, in-process, final product, and stability. Typical hours are 10:00 pm – 6:30 am, Monday through Friday. Hours may vary to meet business and training needs.
II. Essential Functions Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Perform WFI sampling and testing as per current protocol or validation protocols to support the WFI system.
Perform sampling of raw materials.
Perform incoming inspection of raw materials and components.
Clean laboratory glassware using dishwasher or manual washing, if necessary.
Perform TOC testing to support release of production equipment.
Perform daily laboratory tasks, such as balance calibration checks, temperature chart monitoring, CSR duties, etc.
Maintain lab equipment and benches in a clean and neat fashion.
Assist with trending, archiving, and maintaining water data.
Perform various analytical testing procedures as per manufacturing/quality control batch records, stability protocols, raw material requests for testing, etc.
Participate in calibration, troubleshooting, and proactive resolution of instrument issues.
Write, revise, and review SOPs and Testing Standards as necessary.
Review, analyze, interpret, and report data.
Verify and enter approved results in LIMS or batch records.
Participate in investigations, CAPA, change control activities, and related studies.
Practice Good Documentation and Laboratory Safety Procedures per SOPs.
Track time worked per project.
Assist in writing protocols and reports as necessary.
Inform supervisor upon observing out-of-specification results.
Organize final data records and raw material records for review.
Train and assist lab assistants and chemists as necessary.
Support department compliance and productivity goals.
Participation in biomedical screening is required.
III. Minimum Education, Experience, Skills Education:
A minimum of a B.S. in Chemistry or related field
Experience:
0-2 years in a chemistry laboratory or equivalent. GLP/GMP experience preferred. LIMS or SAP experience preferred.
Knowledge:
College-level knowledge of general chemistry or biochemistry principles, math, and writing skills.
Skills:
Intermediate proficiency in Excel and Word, including table building and formatting. Ability to write legibly and record work accurately in written and electronic forms.
Abilities:
Effective communication, ability to complete assigned tasks, improve processes, work independently and in groups, multi-task, and learn computer systems. Proven skills in Excel, Word, LIMS, or SAP are preferred.
IV. Physical/Mental Demands and Work Environment The physical and mental demands are typical for this role. The work environment is as described for performing essential functions.
Compensation Range $47,077.00 - $70,615.00
Bora Pharmaceuticals is committed to equal employment opportunity and nondiscrimination in all employment practices.
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Analyst I, QC Analytical-2nd Shift
role at
Bora Pharmaceuticals
I. JOB SUMMARY Perform analytical testing per cGMP in support of raw material, in-process, final product, and stability. Typical hours are 10:00 pm – 6:30 am, Monday through Friday. Hours may vary to meet business and training needs.
II. Essential Functions Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Perform WFI sampling and testing as per current protocol or validation protocols to support the WFI system.
Perform sampling of raw materials.
Perform incoming inspection of raw materials and components.
Clean laboratory glassware using dishwasher or manual washing, if necessary.
Perform TOC testing to support release of production equipment.
Perform daily laboratory tasks, such as balance calibration checks, temperature chart monitoring, CSR duties, etc.
Maintain lab equipment and benches in a clean and neat fashion.
Assist with trending, archiving, and maintaining water data.
Perform various analytical testing procedures as per manufacturing/quality control batch records, stability protocols, raw material requests for testing, etc.
Participate in calibration, troubleshooting, and proactive resolution of instrument issues.
Write, revise, and review SOPs and Testing Standards as necessary.
Review, analyze, interpret, and report data.
Verify and enter approved results in LIMS or batch records.
Participate in investigations, CAPA, change control activities, and related studies.
Practice Good Documentation and Laboratory Safety Procedures per SOPs.
Track time worked per project.
Assist in writing protocols and reports as necessary.
Inform supervisor upon observing out-of-specification results.
Organize final data records and raw material records for review.
Train and assist lab assistants and chemists as necessary.
Support department compliance and productivity goals.
Participation in biomedical screening is required.
III. Minimum Education, Experience, Skills Education:
A minimum of a B.S. in Chemistry or related field
Experience:
0-2 years in a chemistry laboratory or equivalent. GLP/GMP experience preferred. LIMS or SAP experience preferred.
Knowledge:
College-level knowledge of general chemistry or biochemistry principles, math, and writing skills.
Skills:
Intermediate proficiency in Excel and Word, including table building and formatting. Ability to write legibly and record work accurately in written and electronic forms.
Abilities:
Effective communication, ability to complete assigned tasks, improve processes, work independently and in groups, multi-task, and learn computer systems. Proven skills in Excel, Word, LIMS, or SAP are preferred.
IV. Physical/Mental Demands and Work Environment The physical and mental demands are typical for this role. The work environment is as described for performing essential functions.
Compensation Range $47,077.00 - $70,615.00
Bora Pharmaceuticals is committed to equal employment opportunity and nondiscrimination in all employment practices.
#J-18808-Ljbffr