Quality Control Chemist

Role: Quality Control Chemist

Location: Decatur, Illinois, USA

Duration: Full Time

Must have Minimum: 2 years - liquid sterile injectables experience

Look for a QC Chemist with 5 years of experience in Pharmaceutical QC, preferably in injectable dosage forms. Oral and Liquid dosage is also acceptable.

• Bachelor's or Master's degree in Chemistry.
• Candidate must have strong pharmaceutical quality control experience (Preferably injectable).
• Candidate should handle major QC instruments like HPLC, GC, UV, FTIR, KF, etc.
• Candidate should have work experience in handling software like chromeleon , Lab X etc.
• Candidate should have experience in method validation, stability testing, finished product testing, raw materials, packaging material testing, etc.
• Candidate should know current regulatory guidelines like ICH,21 CFR part 11, ALCOA principle, Data integrity, GLP, etc.
• Candidate should have exposure to regulatory audit. Like USFDA.
• Candidate should have strong experience in writing investigations like OOS, OOT, Lab incidence etc.
• Candidate should have experience in writing GMP document SOPs, protocols, Reports etc.

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*This is a full-time on-site, working in the lab position.
*This is a permanent role, therefore, candidate must be open to relocate/drive and/or living in Decatur, IL Monday – Friday.

Position Description:

Position Title: Quality Control Chemist Department: Quality Control

Reports To: Supervisor of Quality Control Work Location: Decatur, Illinois

Position Summary:

Perform the sampling of raw materials, chemical and physical analysis of raw material, bulk formulations, finished products, stability samples, and any non-routine samples.

Essential Duties & Responsibilities:

· Sampling and testing of raw materials per approved procedure.

· Physical and chemical testing of bulk and (pre-fill, finished product, and stability) product.

· Upkeep of laboratory notebook.

· Maintaining the work area in an orderly manner.

· Maintaining Lab inventory like list of standards, chemical, reagent etc.

· Recording daily activity like PH verification, balance verification, temperature and humidity monitoring of lab stability chambers, freezer, refrigerator etc.

· Experience in the operation of handling QC major instruments like HPLC, GC, UV, IR, Auto titrator, etc.

· Perform Finished product/in-process/cleaning validation and raw material analysis independently.

· Complete testing within specified timeframes and document results accurately

· Coordinate with vendors for instrument PM, calibration and qualification activity.

· Provide necessary support.

· Maintain and monitor lab GLP activity like instrument calibration/qualification schedule, Preparation of instrument operating procedure, coordinate with metrology team and vendor for scheduling period calibration/qualification activity etc.

· Performs calibration of lab instruments whenever possible.

· Cleaning of laboratory glassware.

· Responsible for writing SOP for instrument operation/ calibration etc.

· Provide necessary support for OOS/OOT investigation.

· Preparation of stability schedule, Protocol, and report per ICH requirements.

· Adhere to regulatory guidelines (e.g., FDA, ICH, GMP) and company quality standards during testing and documentation.

· Ensure adherence to Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP) during testing procedure.

Education and Experience:

· Bachelor's Degree from a four-year accredited college or university with a Major in Chemistry or equivalent.

· Prefer two years of industry experience involving analytical or wet chemistry test procedures in a quality control environment.

· Experience with Infra-Red (IR), Ultraviolet/Visible Spectroscopy, Particle Size Analysis, KF Titration, and wet chemistry skills are required.

· Familiarity with High Pressure Liquid Chromatography, Gas Chromatography (GC), and HPLC/GC analytical software is preferred, but not required.

· Familiarity with GLP/GMP guidelines.

· Good Communication and writing skills.

· Familiarity with out-of-specification (OOS) investigation. Computer literate.

· Experience with USP/EP monographs.

Job Prerequisites:

· Ability to meet attendance standards.

· At times it may be necessary to work additional hours to get the required tasks accomplished to meet deadlines.

· Working knowledge of MS Word, Excel, Outlook, and PowerPoint.

· Working knowledge of Adobe Acrobat.

· Excellent conceptualizing, analytical, and problem-solving skills.

· Physical Demands, Mental requirements, and Work Environment:

· While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and hear.

· The employee is required to use hands to finger, handle, or feel.

· Specific vision abilities required by this job include close vision for written work and PC use.

· Requires eye-hand coordination and manual dexterity.

· Requires normal range of hearing and vision to record, prepare and communicate appropriate reports.

· Will come in contact with hazardous materials.

· Employees are expected to work with hazardous materials in a safe manner and use all safety precautions.

Mental Requirements

· Effective written and oral communication skills.

· Strong organizational, planning, and communication skills.

· Using logic and reasoning to identify solutions to problems.

· Ability to multitask, set priorities, and meet strict deadlines.

· Ability to lead, motivate, coach, and teach others.

· Ability to accurately communicate ideas, facts, and technical information.

· Ability to meet deadlines and effectively deal with office stress.

· Ability to follow safety and security practices.

· Ability to receive instructions and follow work rules and company policies.

Thanks

rajesh@cyboticsystems.com

Job Type: Full-time

Pay: $60,000.00 - $70,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Application Question(s):

• How Many years of experience do you have in Sterile Injectables?
• How Many years of experience do you have with the Pharmaceutical Domain?

Experience:

• Quality control: 5 years (Required)

Ability to Commute:

• Decatur, IL (Preferred)

Ability to Relocate:

• Decatur, IL: Relocate before starting work (Required)

Work Location: In person

Salary : $60,000 - $70,000