QC Chemist

Location: Cranbury

Job Title:

QC Chemist

Job Description

As a QC Chemist, you will be responsible for performing day-to-day laboratory activities under prescribed procedures, including qualitative and quantitative analysis, solution preparation, calibration, qualification, and maintenance of laboratory instrumentation. You will also conduct environmental monitoring, assist with technical writing, and perform administrative tasks. Additionally, you will contribute to solving problems, reviewing experimental data, writing protocols/SOPs/validation reports, and training support staff as necessary.

You will monitor study procedures to ensure data accuracy and report quality while maintaining a GMP/GLP laboratory.

Responsibilities

* Conduct analysis in compliance with cGMP requirements, compendia standards, and internal procedures.

* Maintain accurate records of analysis and perform documentation to company standards.

* Prepare test solutions, volumetric solutions, and samples used in analysis.

* Perform assigned sampling, physical, chemical tests and assays on raw materials, active pharmaceutical ingredients, in-process, finished bulk, finished product, and stability products analysis in an FDA regulated lab environment.

* Use a variety of analytical instruments such as HPLC, GC, Dissolution, Malvern particle size analyzer, IR, Auto Titrator, UV Spectrophotometer, KF, Potentiometer, etc.

* Perform analysis with a practical understanding of the test procedure and instrument operation.

* Conduct laboratory investigations under the supervision of the laboratory manager.

* Perform maintenance and calibrations of laboratory instruments/equipment.

* Comply with all regulatory and in-house requirements including safety, housekeeping, laboratory chemical waste, cGMP, cGLP, and documentation.

* Maintain the required level of training needed to perform GMP tasks.

* Prepare and/or review test procedures, SOPs, and protocols as assigned.

Essential Skills

* Proficiency in current Good Manufacturing Practices (cGMP), FDA, and other regulatory requirements.

* Experience with analytical techniques such as Dissolution, FT-IR, GC, UV-VIS, KF, TLC.

* Knowledge of computer applications and programs related to laboratory applications such as HPLC, FTIR, TOC.

* Familiarity with sampling methods and quality control systems.

* Understanding of mathematics including statistics.

* Proficiency in sample preparation techniques, spectroscopic techniques, and chromatographic systems.

* Basic computer knowledge including MS Word, Excel, and Outlook.

* 3-5 years of routine testing using HPLC and Dissolution.

* Experience with solid oral dosage and focus on raw material, finished product.

* Pharma GMP experience, laboratory, wet chemistry, titration, chromatography.

Additional

Skills & Qualifications

* Bachelor's or master's degree in Pharmaceutical, Biological, Chemical science or related field.

* 5-6 years of related laboratory work experience; minimum of 5 years as a QC Chemist in a GMP environment.

* Ability to work successfully in both a team/matrix environment and independently.

* Ability to work in a fast-paced environment, manage priorities and maintain timelines for multiple projects.

* Ability to work safely in a chemical laboratory.

* Ability to perform basic calculations, read, write, communicate, and handle stress produced by time pressure, customer demands, etc.

* Must be able to access all laboratory, manufacturing, and office areas.

* Must be able to wear the required PPE for entering laboratory and processing areas.

* Specific vision requirements include reading written documents and using a computer.

* Ability to sit or stand for prolonged periods and occasionally lift up to 25 lbs. with or without assistance.

Work Environment

You will be working in a laboratory setting with approximately 10 people. The laboratory is equipped with modern instrumentation and follows strict safety and regulatory protocols. The work environment requires wearing personal protective equipment (PPE) and involves standing or sitting for prolonged periods. The laboratory operates under a fast-paced and dynamic atmosphere, providing an excellent opportunity for growth and development.

Pay and Benefits

The pay range for this position is $30.00 - $40.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

* Medical, dental & vision

* Critical Illness, Accident, and Hospital

* 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available

* Life Insurance (Voluntary Life & AD&D for the employee and dependents)

* Short and long-term disability

* Health Spending Account (HSA)

* Transportation benefits

* Employee Assistance Program

* Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Cranbury,NJ.

Final date to receive…