Chemist B

Merck & Co.; Durham (NC); On-site; USD 65,000 - 75,000; Full time

Benefits offered by this job

Medical plans

Dental benefits

Vision plan

Life Insurance

Disability Insurance

401(k) plan

Job summary

Aurolife, a Merck-affiliated pharmaceutical division, seeks a Chemist B to ensure products and materials meet quality standards by performing analytical tests and maintaining documentation. This role requires strong attention to detail, GMP compliance, and ability to work in regulated environments.

The position involves testing raw materials, APIs, in-process and finished goods using methods like HPLC, GC, UV-Vis, and IR, with responsibilities spanning SOPs, calibration, documentation, and

Qualifications

• BS in Chemistry or related scientific field.
• 3–5 years experience in pharmaceuticals with 2–4 years in analytical testing.
• Knowledge of USP/ICH/FDA regulations and Good Documentation practices.

Responsibilities

• Perform physical, chemical and instrumental tests on raw materials, APIs, in-process, finished and stability products using wet chemicals and instrumental techniques per USP/In-house/any other Compendial monographs.
• Independently plan and inventory test reagents and solutions to ensure supplies.
• Plan and execute testing to meet established timelines; perform complex tests with supervisory direction.
• Record data and results as specified in documentation procedures; document work clearly.
• Prepare and/or review Test Procedures, SOPs, and Protocols as assigned.
• Perform maintenance and calibrations of laboratory instruments with supervisory direction.
• Troubleshoot and investigate under supervision.
• Comply with regulatory/in-house requirements (safety, housekeeping, waste, cGMP, cGLP, documentation).
• Review Analytical documents as required.

Skills

Pharmaceutical experience

Analytical testing

Documentation practices

Regulatory knowledge

Decision making

Education

BS in Chemistry

Tools

HPLC

GC

UV-Vis

IR

KF Auto titrator

Particle Size Analyzer

Job description

Division Overview

Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.

Job Overview

Chemist B is responsible for ensuring that products and materials meet established quality standards and regulatory requirements by conducting laboratory tests, analyzing results, and maintaining accurate documentation. They perform testing on raw materials, in-process samples, and finished goods using various analytical techniques, while adhering to standard operating procedures (SOPs), Standard test procedure and Good Manufacturing Practices (GMP). QC Analysts also investigate discrepancies such as out-of-specification results, support corrective actions, maintain laboratory equipment, and ensure compliance with regulatory guidelines. This role requires strong attention to detail, technical expertise, and the ability to work in regulated environments.

Responsibilities

1. Perform physical, chemical and instrumental tests 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 USP monograph / In-house / any other Compendial monographs.
2. Independently plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work.
3. Independently plan and execute testing to meet established time lines. Perform complicated testing with supervisory direction.
4. Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately.
5. Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned.
6. Perform maintenance and calibrations of laboratory instruments/equipments with supervisory direction/training.
7. Perform troubleshooting and investigations under the direction of a supervisor.
8. 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.
9. Review of Analytical documents as required

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 preferred

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

Min: USD $65,000.00/Yr.

Max: USD $75,000.00/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

No Additional 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.