Chemist

Chemist

Job Description

Analyze raw materials, finished products, and stability samples by HPLC and other specialized testing methodologies. Provide training and support to other QC lab personnel.

PRIMARY RESPONSIBILITIES:

• Test raw materials, finished products, stability samples by HPLC and other specialized testing methodologies (including proper documentation of all test results)
• Test samples supporting process validations and cleaning validations (including proper documentation of all test results)
• Perform method development and validation of test methods to support R&D activities and FDA submissions (including proper documentation of all test results)
• Assist in the creation of written test methods as requested
• Provide support for the complete testing of raw material/vendor qualification
• Train and support QC lab personnel on testing procedures
• Create standard operating procedures followed by the quality QC lab as requested
• GC residual solvent method development and validation experience
• GC Agilent 7890A experience with troubleshooting
• GC testing by USP with packed and capillary column method optimization (USP) to development to verification and or validation experience
• Advanced Empower software experience with custom field, report creation and optimization
• Waters Acquity, UPLC experience with method development and troubleshooting and PM/IQ/OQ
• Well versed with cGMP, cGLP and other guidelines (ICH, USP, FDA etc)
• Maintain and qualify reference standards
• Procure lab supplies, chemicals, glassware and equipment
• Follow proper health and safety guidelines (i.e. PPE, safety regulations, etc.)
• Work in accordance with all company policies and procedures
• Perform other duties and special assignments as assigned

QUALIFICATIONS:

Education and/or Experience:

• Minimum BS degree in Chemistry or related field
• 0-5 years experience in a QC lab setting. Preferably in pharmaceuticals
• Experience operating and programming HPLC
• Experience using millennium and/or empower software
• Familiarity with USP/NF and other compendia preferable
• Experience in wet chemistry with some use of instruments
• Ability to work independently with minimal supervision

Training:

On the job training:

• MSDS/Hazardous Awareness
• cGMP
• Training to conduct tests for the release of raw materials, stability samples and finished products
• IR spectrophotometer and UV/VIS spectrophotometer
• HPLC and other instruments and complete testing of raw materials as per compliance requirements
• appropriate SOP’s per department requirements

Reasoning Ability:

• Ability to multi-task running equipment and documenting data
• Perform mathematical calculations by hand or with software
• Perform root cause analysis and troubleshoot problems
• Ability to follow directions to accurately perform tests

TOOLS AND EQUIPMENT:

• Computer to create or update forms and documents use in the lab
• Phone
• Fax machine
• Copy machine
• HPLC systems
• UV/VIS spectrophotometer
• IR spectrophotometer
• Dissolution apparatus
• Viscometer
• Conductivity/pH meter
• Karl Fisher
• TLC apparatus
• GC instrument
• Furnace, ovens, burners, etc.
• Balances
• pH meter
• Stir plates and hot plates
• Moistures meter
• Use of burettes for titrations
• Lab glassware such as flask, beaker, graduated cylinder
• Various other instruments and apparatus

Appropriate personnel protective equipment (when necessary)

Job Type: Full-time

Benefits:

• 401(k)
• Health insurance
• Paid time off
• Vision insurance
• Dental insurance
• Flexible spending account

Schedule:

• 10 hour shift

Ability to commute/relocate:

• Elgin, IL 60123: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Laboratory experience: At minimum 1 year (Preferred)

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 10 hour shift
• 8 hour shift

Application Question(s):

• What is your expected compensation range?
• Are you authorized to work in the United States?
• Do you require sponsorship to continue to work in the United States?

Ability to Commute:

• Elgin, IL 60123 (Required)

Ability to Relocate:

• Elgin, IL 60123: Relocate before starting work (Required)

Work Location: In person