Chemist C

Job Overview

The QC Chemist C role involves performing various quality control tests to ensure the strength, identity, and purity of test samples and materials. This role also includes working as part of the stability team to execute QC analytical testing using established procedures.

Responsibilities

• Perform assigned in-process, finished product, and stability product testing using various wet chemicals, physical, and instrumental techniques (HPLC, UPLC, GC, UV-Vis, IR, Particle Size Analyzer, KF Auto titrator, Bulk Density, etc.) as per finished product methods.
• Independently plan and execute testing to meet established timelines.
• Perform complicated testing with little supervisory direction.
• Absorb and apply knowledge of EMPOWER Chromatography Data System and LIMS.
• Assist with the preparation or review of Test Procedures, SOPs, Protocols, and CoAs as assigned.
• Record data and results as specified in documentation procedures.
• Document work clearly and perform tests accurately.
• Perform maintenance and calibrations of laboratory instruments/equipment with little supervisory direction/training.
• Perform troubleshooting and investigations under the direction of a supervisor.
• Absorb and apply knowledge of USP/ICH/FDA guidelines.
• Review analytical documents.
• Investigate for OOS/OOT/Deviation and other lab related events.

Qualifications & Requirements

• Knowledge of EMPOWER Chromatography Data System and LIMS.
• QC experience in Generic Pharmaceutical industries preferred.
• Experience in a cGMP environment required.
• Knowledge and use of Good Documentation practices.
• Knowledge of USP/ICH/FDA guidelines.
• Team player who assists junior colleagues.
• Willing to work flexible hours to meet product deliverables.
• Ability to learn quickly and have decision-making skills adhering to regulatory practices.
• Education & Experience: BS or MS in Chemistry or Pharmaceutical Sciences, or related field. Minimum 5+ years of experience in Pharmaceuticals and Analytical testing is desirable. Preference shall be given for experience in Inhalation testing on a variety of Inhalation products.

Benefits

• Medical and Rx Benefits choice of four medical plans through Horizon. Rx automatically provided with medical benefits.
• Dental Benefits with three dental plan options through CIGNA.
• Vision Plan with two plan options through VSP.
• Limited Life Insurance.
• Flexible Spending Accounts (FSA) - Both Health Care & Dependent Care.
• Health Savings Account (HSA).
• 401(k) Plan - Through Fidelity / Employer Match / fully vested after 3 years.
• Employee Assistance Program (EAP) - 100% Confidential and 100% company paid.
• Critical Illness and Accidental Insurance.
• Legal and Identity Theft Insurance.
• Paid Time Off - Paid vacation, PTO, Holiday Notice.

Compensation

Min USD $80,000.00/Yr. Max USD $89,000.00/Yr.

Physical Requirements

• Laboratory technician must be able to bend at the waist and knees as well as twist at the trunk.
• Must practice good personal hygiene.
• Must be able to lift up to 25 lbs.
• Must be able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves.
• PPE and Respirators are essential for the health and safety of employees.