Job Title: Quality Control Chemist

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

Position Summary:

The Quality Control Chemist will perform sampling and chemical and physical analysis of raw materials, bulk formulations, finished products, stability samples, and any non-routine samples. This role ensures compliance with regulatory guidelines and company quality standards during testing and documentation.

Essential Duties & Responsibilities:

• Sample and test raw materials per approved procedures.
• Conduct physical and chemical testing of bulk and finished products, including stability samples.
• Maintain accurate laboratory notebooks and documentation.
• Keep work areas orderly and maintain lab inventory.
• Record daily activities such as pH verification, balance verification, and temperature/humidity monitoring of lab equipment.
• Operate major QC instruments like HPLC, GC, UV, IR, and Auto titrators.
• Perform independent analysis of finished products, in-process materials, and raw materials.
• Complete testing within specified timeframes and document results accurately.
• Coordinate with vendors for instrument preventive maintenance, calibration, and qualification activities.
• Support OOS/OOT investigations and prepare stability schedules, protocols, and reports per ICH requirements.
• Adhere to regulatory guidelines (e.g., FDA, ICH, GMP) and company quality standards.
• Ensure compliance with GLP, GDP, and GMP during testing procedures.
• Clean laboratory glassware and maintain lab GLP activities.
• Write SOPs for instrument operation and calibration.
• Support the Quality Management System (QMS) with a focus on 5S methodology.

Education and Experience Requirements:

• Bachelor's or Master's degree in Chemistry from an accredited college or university.
• Minimum of 1 year of relevant experience as a Quality Control Chemist, preferably in pharmaceutical QC with a focus on injectable dosage forms.
• Experience with major QC instruments (HPLC, GC, UV, FTIR, KF).
• Familiarity with analytical software like Chromeleon and Lab X.
• Experience in method validation, stability testing, finished product testing, raw materials, and packaging material testing.
• Knowledge of current regulatory guidelines (ICH, 21 CFR part 11, ALCOA principles, Data Integrity, GLP).
• Experience with regulatory audits (e.g., USFDA).
• Strong experience in writing investigations (OOS, OOT) and GMP documents (SOPs, protocols, reports).

Skills:

• Proficiency in using MS Word, Excel, Outlook, and PowerPoint.
• Familiarity with Adobe Acrobat.
• Excellent conceptual, analytical, and problem-solving skills.
• Effective communication and writing skills.
• Ability to manage multiple tasks and meet strict deadlines.
• Strong organizational and planning abilities.
• Ability to work with hazardous materials safely and follow all safety precautions.

Physical Demands & Work Environment:

• Regularly required to sit, stand, walk, talk, and hear.
• Use hands to finger, handle, or feel.
• Close vision required for written work and PC use.
• Requires eye-hand coordination and manual dexterity.
• Normal range of hearing and vision needed.
• Exposure to hazardous materials expected.

Job Prerequisites:

• Ability to meet attendance standards and work additional hours as needed.
• Ability to follow safety and security practices.
• Must be a USA Citizen, Green Card Holder, or H1B Visa hold an appropriate work permit (EAD).

Benefits:

• Full benefits package including medical, dental, vision insurance, STD/LTD, 401K with 100% match up to 4%, PTO, 8 paid holidays, health savings plans, and life insurance.
• Relocation expenses are considered on a case-by-case basis.

Note: This is a full-time, on-site position in Decatur, IL, Monday – Friday. The candidate must be open to relocating or commuting to Decatur.

If you have the required experience and are looking for a challenging role in a dynamic environment, we encourage you to apply.

Job Type: Full-time

Schedule:

• 8 hour shift
• Monday to Friday

Application Question(s):

• Kindly mention your regular email and phone number to Connect and schedule an interview.
• Please provide two available time slots for the next 2-3 days to schedule interviews. (Please provide specific Date & Time, Time Zone)
• Are you Based in Decatur, Illinois or willing to commute/ relocate to Decatur, Illinois for this position?
• What is your expected annual base salary for this position?
• How many years of current experience do you have as a QC chemist?
• What is the citizenship/ Work authorization? (US Citizen/ Green card Holder/ H1B transfers/ Work Permit (EAD))
• Out of the below, what applies to you?

A. Have current experience with Sterile Injectables
B. Have past working experience with Sterile Injectables
C. Has good experience with current/past Liquid Oral Dosage
D. Has experience with only Oral Solid dosage

• How many years of experience do you have working in Pharmaceutical Manufacturing company?
• Do you have experience with Sterile Injectables/ Liquid Oral Dosage/ Oral Solid dosage? If yes, How many years of experience do you have?

Education:

• Bachelor's (Required)

Work Location: On the road