Associate Scientist II, Quality Control

The Role

• Analyze finished products, in-process materials, fill moisture, raw materials, and cleaning verification and validation samples according to assigned specifications, methods, and protocols.
• Perform analysis of finished products, validation samples, moisture testing, gas, water, and environmental sampling and testing following effective specifications, protocols, and compendial monographs.
• Cultivate and identify microorganisms on selective and non-selective media; maintain cultures per ATCC and departmental Standard Operating Procedures.
• Identify microorganisms using techniques such as API and Gram Stain.
• Prepare reagents, standards, and media needed for analysis.
• Work with potent and teratogenic compounds as required.
• Log samples into GLIMS database and logbooks; interpret and record results in approved notebooks, reports, and logbooks.
• Perform basic statistical analysis to support testing; verify calculations and results for accuracy and integrity.
• Assist with receiving, labeling, and storing solvents and reagents; maintain inventory of glassware, chemicals, and materials.
• Calibrate analytical equipment such as balances, pH meters, and KF analyzers; maintain and clean laboratory instruments and equipment.
• Dispose of hazardous waste according to regulations and procedures.
• File and maintain laboratory records following Good Manufacturing Practices and applicable SOPs.
• Assist in writing, reviewing, or revising procedures and laboratory investigations.
• Perform other laboratory-related duties as required, including cleaning glassware.
• Work shifts in support of manufacturing, including weekends and holidays; hours may change based on departmental needs.

The Candidate

Minimum Requirements

• Bachelor’s degree required.
• Ability to work effectively under pressure to meet deadlines.
• Ability to sit, stand, walk regularly and occasionally lift up to 15 pounds; no lifting greater than 44.09 pounds without assistance.
• Vision requirements include ability to differentiate color (pass the Ishihara Color Vision Screening) and obtain 20/30 acuity in both far and near vision with or without corrective lenses. For Catalent’s in-house screening, the acceptable score is to identify at least 4 of 6 numbers in the circles.
• Be accessible to manufacturing, laboratory, and office staff.
• Ability to use required office equipment.

Preferred Skills & Background

• UV spectroscopy, IR and AA instrumentation, HPLC and GC instrumentation, autoclave and Vitek systems, dissolution testing, Wet chemistry techniques such as titrations, extractions, digestions, and preparation of test solutions.
• Knowledge of safety and hazardous waste requirements, data acquisition applications and databases, and conducting and writing laboratory investigations.