Chemist C

Job Overview

The QC Chemist C will perform a variety of QC testing to assess the strength, identity, and purity of test samples and/or materials. They will work as a member of the stability team to effectively execute QC analytical testing using established (official and/or in-house) test 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, and other routine QC instruments) as per Finished Product methods.
• Independently plan and execute testing to meet established time-lines.
• Perform complicated testing with little supervisory direction.
• 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.
• Assist in drafting deviation reports as assigned.
• Comply with all regulatory/in-house requirements (may include but not limited to safety, housekeeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity.
• Review of analytical documents
• Investigation 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 would be preferable
• Experience in a cGMP environment is required
• Knowledge and use of Good Documentation practices
• Knowledge of USP/ICH/FDA guidelines
• Team player who will assist junior colleagues
• Willing to work flexible hours to meet product deliverables
• Ability to learn quickly and have decision-making skills that adhere 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
• 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 (FSAs) – 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

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.
• Position requires working in the laboratory as well as sitting.

Additional Physical Requirements

• No additional requirements

Compensation

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