Chemist C

Job Overview

The Chemist-C will perform a variety of QC testing to assess the strength, identity, and purity of test samples and/or materials. The Chemist-C will work as a member of a team to effectively plan and QC analytical testing using established (official and/or in-house) test procedures.

Responsibilities

• Perform assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemicals, physical and instrumental techniques (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, KF Auto titrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs.
• Independently plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work.
• Independently plan and execute testing to meet established time lines.
• Perform complicated testing with supervisory direction.
• Record data and results as specified in documentation procedures.
• Document work clearly and perform tests accurately.
• Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned.
• Perform maintenance and calibrations of laboratory instruments/equipments with supervisory direction/training.
• Perform troubleshooting and investigations under the direction of a supervisor.
• Comply with all regulatory/in-house requirements (may include but not limited to safety, house keeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity.
• Review of Analytical documents as required.
• Active involvement in training and qualification of newly hired chemists.
• Be a role model and mentor to lesser experienced analysts in the team.

Qualifications

• Knowledge in Good Documentation practices.
• Knowledge in USP/ICH/FDA.
• Ability to learn quickly and decision making skills.
• Attention to detail and documentation.
• Proficient in working with Empower and LIMS.
• 2-4 years of experience with handling Out Of Specification investigations.

Education & Experience

• Minimum BS within Scientific field, BS with Chemistry is one of the subjects would be preferable.
• Minimum 4-6 years experience in pharmaceuticals and must have 3-5 year experience in Analytical testing.
• 3 years QC experience in Generic Pharmaceutical industries would be preferable.

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 Notice.

Compensation

Min USD $85,000.00/Yr. Max USD $90,000.00/Yr.

Physical Requirements

• Field - While performing the duties of this job the employee is required to: Work in a temperature controlled office environment or travel via vehicle or commercial transportation.
• While performing the duties of this job, the employee is occasionally required to handle or feel objects, talk, hear, and walk during the course of employment.
• Position requires some degree of travel for business purposes.
• Employee may use computer, phone, copier and other office equipment in the course of a day.
• Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and an ability to adjust focus.
• Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body.
• Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Additional Physical Requirements Lifting 8+ Hours - 0-10 Pounds 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.