Position Summary:

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

Must Have:

• 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.

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 Types: Contract, Temporary

Pay: $60,000.00 - $65,000.00 per year

Benefits:

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

Schedule:

• Day shift
• Evening shift

Experience:

• Quality Control Chemist: 5 years (Required)
• Oral and Liquid dosage: 2 years (Required)
• QC instruments like HPLC, GC, UV, FTIR, KF: 4 years (Required)
• Raw materials, Stability testing, Finished product testing: 2 years (Required)
• CH,21 CFR part 11, ALCOA principle: 2 years (Required)
• Injectable: 1 year (Required)

Ability to Commute:

• Decatur, IL (Required)

Work Location: In person