Chemist I
Quick Apply Full-time 4 hours ago Full Job Description Position Description:
Independently performs routine QC and R&D testing for raw materials, intermediates and components used in the manufacturing process at the Miami Lakes Site as well as finished products.
Performs testing in accordance with USP, FDA, ICH regulatory requirements, established standard procedures and R&D Policy Guide, as applicable, involving instrumentation and quantitative analysis.
Essential Duties and Responsibilities Performs routine quality control and R&D testing on raw materials, in-process, finished products, components, drug substance and stability samples according to written procedures and official compendia in compliance with cGMP, environmental and safety regulations, FDA, cGMP, GLP, ICH , R&D Policy guide and other applicable guidelines.
Proficiently operate, maintain, qualify and calibrate the instrumentation/equipment associated with testing such as like HPLC, GC, FTIR, UV-Vis, Karl Fisher, Analytical balances, Water activity meter, Polarimeter and many more.
Method development or method validation for testing raw materials, components, drug substance and drug products (Commercial and R & D) Perform Dissolution for drug products for routine testing, stability testing and regulatory submission.
Perform Cleaning verification and validation.
Prepare review and approval of operational, quality-relevant and regulatory-relevant documentation such as SOPs, Specifications, Test Methods, Protocols, Analytical Reports, Validation Reports, etc.
Investigate product quality issues including taking care of incidents, investigations pertaining to material testing and compliance Training and development of quality unit staff.
Provide support with safety program (along OSHA guidelines), Compliance of the laboratory policies applicable at LPI.
Has knowledge and understanding of the quality system.
Assess system to ensure that the site remains current and compliant.
Participates in activities associated with internal/external audits, when required.
Performs other job-related duties as assigned.
Technical Knowledge and Skills:
Ability to identify and solve problems, and to independently manage multiple activities/projects to ensure timely completion Utilize scientific based rationale and risk based analysis decision-making tools.
Ability to provide leadership behaviors including change management, and communication.
Ability to work in a team environment.
Ability to work various computer applications o Excellent verbal and written communication skills.
o Overall knowledge of Laboratory equipment operation and calibration.
Education:
Minimum BS degree in Chemistry with 1-3 years of experience Must possess knowledge of HPLC, UV-Vis, Dissolution Apparatus and TLC principles.
PHYSICAL REQUIREMENTS:
Work safely and follow all OSHA regulations and company safety policies and procedures Works frequently in a lab environment, handling of chemicals Employees are required to wear eye protection and lab coats while in the lab area Ability to frequently lift and/or move up to 25 lbs Ability to occasionally lift and/or move up to 35 lbs Ability to regularly stand, sit, and walk to perform tasks What We Offer:
Competitive Wages Medical & Dental (company pays 75% of employee's HMO plans) Discounted Vision 401k - company will match up to 3% of annual salary Paid Holidays 2 Floating Holidays PTO Paid by the company Life Insurance, STD and LTD at no cost to employee EAP Programs/ Discounts Job Type:
Full-time Pay:
$50,000.
00 - $55,000.
00 per year
Benefits:
401(k) 401(k) matching Dental insurance Flexible schedule Health insurance Paid time off Relocation assistance Tuition reimbursement Vision insurance Schedule:
8 hour shift Monday to Friday Overtime Weekend availability Work Location:
One location Independently performs routine QC and R&D testing for raw materials, intermediates and components used in the manufacturing process at the Miami Lakes Site as well as finished products.
Performs testing in accordance with USP, FDA, ICH regulatory requirements, established standard procedures and R&D Policy Guide, as applicable, involving instrumentation and quantitative analysis.
Quick Apply.
Estimated Salary: $20 to $28 per hour based on qualifications.
Independently performs routine QC and R&D testing for raw materials, intermediates and components used in the manufacturing process at the Miami Lakes Site as well as finished products.
Performs testing in accordance with USP, FDA, ICH regulatory requirements, established standard procedures and R&D Policy Guide, as applicable, involving instrumentation and quantitative analysis.
Essential Duties and Responsibilities Performs routine quality control and R&D testing on raw materials, in-process, finished products, components, drug substance and stability samples according to written procedures and official compendia in compliance with cGMP, environmental and safety regulations, FDA, cGMP, GLP, ICH , R&D Policy guide and other applicable guidelines.
Proficiently operate, maintain, qualify and calibrate the instrumentation/equipment associated with testing such as like HPLC, GC, FTIR, UV-Vis, Karl Fisher, Analytical balances, Water activity meter, Polarimeter and many more.
Method development or method validation for testing raw materials, components, drug substance and drug products (Commercial and R & D) Perform Dissolution for drug products for routine testing, stability testing and regulatory submission.
Perform Cleaning verification and validation.
Prepare review and approval of operational, quality-relevant and regulatory-relevant documentation such as SOPs, Specifications, Test Methods, Protocols, Analytical Reports, Validation Reports, etc.
Investigate product quality issues including taking care of incidents, investigations pertaining to material testing and compliance Training and development of quality unit staff.
Provide support with safety program (along OSHA guidelines), Compliance of the laboratory policies applicable at LPI.
Has knowledge and understanding of the quality system.
Assess system to ensure that the site remains current and compliant.
Participates in activities associated with internal/external audits, when required.
Performs other job-related duties as assigned.
Technical Knowledge and Skills:
Ability to identify and solve problems, and to independently manage multiple activities/projects to ensure timely completion Utilize scientific based rationale and risk based analysis decision-making tools.
Ability to provide leadership behaviors including change management, and communication.
Ability to work in a team environment.
Ability to work various computer applications o Excellent verbal and written communication skills.
o Overall knowledge of Laboratory equipment operation and calibration.
Education:
Minimum BS degree in Chemistry with 1-3 years of experience Must possess knowledge of HPLC, UV-Vis, Dissolution Apparatus and TLC principles.
PHYSICAL REQUIREMENTS:
Work safely and follow all OSHA regulations and company safety policies and procedures Works frequently in a lab environment, handling of chemicals Employees are required to wear eye protection and lab coats while in the lab area Ability to frequently lift and/or move up to 25 lbs Ability to occasionally lift and/or move up to 35 lbs Ability to regularly stand, sit, and walk to perform tasks What We Offer:
Competitive Wages Medical & Dental (company pays 75% of employee's HMO plans) Discounted Vision 401k - company will match up to 3% of annual salary Paid Holidays 2 Floating Holidays PTO Paid by the company Life Insurance, STD and LTD at no cost to employee EAP Programs/ Discounts Job Type:
Full-time Pay:
$50,000.
00 - $55,000.
00 per year
Benefits:
401(k) 401(k) matching Dental insurance Flexible schedule Health insurance Paid time off Relocation assistance Tuition reimbursement Vision insurance Schedule:
8 hour shift Monday to Friday Overtime Weekend availability Work Location:
One location Independently performs routine QC and R&D testing for raw materials, intermediates and components used in the manufacturing process at the Miami Lakes Site as well as finished products.
Performs testing in accordance with USP, FDA, ICH regulatory requirements, established standard procedures and R&D Policy Guide, as applicable, involving instrumentation and quantitative analysis.
Quick Apply.
Estimated Salary: $20 to $28 per hour based on qualifications.
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