Chemist B

Job Title

Responsible for performing sampling, testing, and analysis of raw materials, in-process materials, finished products, and stability samples in accordance with approved specifications, test methods, and regulatory requirements.

Operates and maintains analytical instruments, accurately documents and reviews analytical data, and ensures compliance with cGMP, cGLP, Data Integrity, and safety requirements. Supports laboratory investigations, instrument calibration and maintenance activities, preparation and review of laboratory documents, and contributes to the timely release of materials and products while maintaining the highest standards of quality, accuracy, and regulatory compliance.

Responsibilities

• Perform sampling and routine/advanced physical, chemical, and instrumental analyses of raw materials, active pharmaceutical ingredients (APIs), in-process samples, finished products, cleaning validation samples, and stability samples.
• Conduct testing using laboratory instruments including HPLC, GC, UV-Visible Spectrophotometer, FTIR, Particle Size Analyzer, Karl Fischer Auto Titrator, Bulk Density Apparatus, and other QC laboratory equipment.
• Independently plan daily laboratory activities to ensure timely completion of assigned testing.
• Prepare, standardize, and maintain adequate inventories of reagents, volumetric solutions, standards, and laboratory consumables.
• Organize and prioritize testing activities to meet established timelines and business requirements.
• Independently perform routine testing and support execution of complex analyses under the guidance of senior staff or supervisors.
• Ensure timely reporting of analytical results and notification of any atypical findings.
• Accurately record raw data, calculations, observations, and test results in controlled laboratory records and electronic systems.
• Ensure all documentation complies with Good Documentation Practices (GDP) and ALCOA+ Data Integrity principles.
• Prepare, revise, and review analytical test procedures, standard operating procedures (SOPs), specifications, protocols, reports, and laboratory documentation as assigned.
• Perform routine calibration, verification, maintenance, and qualification activities of laboratory instruments and equipment as per approved procedures.
• Maintain instrument logbooks and ensure equipment remains in a qualified and compliant state.
• Participate in laboratory investigations including OOS, OOT, deviations, atypical results, and laboratory incidents.
• Assist in troubleshooting analytical methods, instruments, and test-related issues under supervisory guidance.
• Support implementation of corrective and preventive actions (CAPA).
• Perform technical review of analytical data, laboratory notebooks, worksheets, chromatograms, calculations, and associated documentation.
• Verify compliance with approved methods, specifications, and documentation requirements prior to result reporting.

Qualifications - Skills & Requirements

• Minimum 3-5 years experience in pharmaceuticals and must have 2-4 year experience in Analytical testing
• Experience in Generic Pharmaceutical industries would be preferable
• Knowledge in Good Documentation practices. Knowledge in USP/ICH/FDA
• Ability to learn quickly and decision making skills.

Education & Experience

• Minimum BS with Scientific field
• BS with Chemistry is one of the subjects would be preferable

Compensation

Min USD $65,000.00/Yr. Max USD $75,000.00/Yr.

Physical Requirements

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 Blood/Fluid Exposure Risk Category II: Usual tasks do not involve exposure to blood, body fluid, or tissues but job may require performing unplanned Category I tasks.