Chemist C

QC Chemist C

QC Chemist C will perform a variety of QC testing to assess the strength, identity and purity of test samples and/or materials. Will work as a member of the stability team to effectively execute QC analytical testing using established test procedures. This role will entail 80% - 100% of their work being performed at the bench level. The Chemist C will be responsible for review of analytical documents, investigations, maintain the GLP status in lab.

Responsibilities

• Perform assigned in-process, finished product and stability product testing, using various wet chemicals, physical and instrumental techniques 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 when performing the assigned activity.
• Review of analytical documents
• Investigation for OOS/OOT/Deviation and other lab related events

Qualifications - Skills & 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 is required

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
• Life Insurance, Basic Life and AD&D and Supplemental Life Insurance
• Disability Insurance, Voluntary Short-Term Disability and State Disability
• Long-Term Disability (LTD), State (short term) disability – where applicable
• FSA (Flexible Spending Accounts) – Both Health Care & Dependent Care Available
• HSA (Health Savings Account)
• 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

Compensation MinUSD $80,000.00/Yr. MaxUSD $89,000.00/Yr. Physical Requirements

LAB TECHNICIANS - 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 Blood/Fluid Exposure Risk Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.