Manufacturing Operator

Merck & Co.; Durham (NC); On-site; USD 23,000 - 29,000; Full time

Job summary

Aurolife, part of Merck & Co., is seeking a Manufacturing Operator responsible for batch manufacturing and packaging in a GMP environment. The role includes operating and cleaning equipment, in-process testing, sampling, dispensing, and supporting calibrations.

Candidates should have a high school diploma and 1-2 years pharma production experience; familiarity with calipers/balances; prior cGMP exposure.

Qualifications

• Follow detailed written procedures and documentation requirements.
• Basic understanding of mechanical equipment and troubleshooting.
• Familiarity with GMP documentation and record-keeping.

Responsibilities

• Perform batch manufacturing operations according to approved batch records, SOPs, and safety standards.
• Execute pharmaceutical processing (filling, coating, cutting, etc) and packaging processes.
• Verification of dispensed raw / packaging materials as required.
• Conduct in-process checks and sampling during manufacturing and packaging stages.

Skills

Attention to detail

Documentation

Mechanical troubleshooting

Follow procedures

Communication

Measurement tools

Education

High school diploma or equivalent

1-2 years in Pharmaceutical / Nutraceutical Production

Tools

Calipers

Balances

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

The Manufacturing Operator is responsible for executing all activities related to batch manufacturing and packaging in accordance with established procedures, safety requirements, and quality standards. This includes operating and cleaning equipment, conducting in-process testing and sampling, performing dispensing activities, supporting calibrations, and troubleshooting machinery as needed. The operator also performs verifications using specialized instruments such as calipers and balances to ensure compliance with product specifications.

Responsibilities

Manufacturing & Packaging

• Perform batch manufacturing operations according to approved batch records, SOPs, and safety standards.
• Execute pharmaceutical processing (filling, coating, cutting, etc) and packaging processes.
• Verification of dispensed raw / packaging materials as required.
• Conduct in-process checks and sampling during manufacturing and packaging stages.

Equipment Cleaning & Maintenance

• Clean and sanitize equipment, tools, and production areas as per Standard Operating Procedures / Protocols.
• Assist with basic maintenance, calibration, and verification activities for production equipment.
• Troubleshoot equipment issues and elevate when needed to minimize downtime.

Quality & Compliance

• Complete all required forms, logs, and documentation accurately and in a timely manner.
• Follow all SOPs, GMP guidelines, and safety procedures.
• Support departmental requests related to developmental, investigative, or quality-related activities.

Additional Duties

• Perform packaging and labeling activities as assigned.
• Operate various production equipment safely and efficiently.
• Assist in training new operators when required.
• Perform other duties as assigned by management.
• Make self availability for the cGMP / Hands-On / Classroom trainings and complete all applicable training forms in a timely manner.
• Troubleshooting the manufacturing equipment operational issues as needed.

Qualifications - Skills & Requirements

• Ability to follow detailed written procedures and documentation requirements.
• Basic understanding of mechanical equipment and troubleshooting.
• Strong attention to detail and commitment to quality.
• Ability to work independently and within a team environment.
• Familiarity with measurement tools (balances, calipers, etc.) preferred.
• Be able to effectively communicate with Production team mates, Supervisor and cross functional team including Quality Assurance, Quality Control, Warehouse and Facilities & Engineering.
• Possess the ability to analyze information and make consistently good decisions

Education & Experience

• High school diploma or equivalent / higher required.
• Should have wok experience of equipment operation, product changeovers, cleaning and basic operational troubleshooting for at-least 1 - 2 years in Pharmaceutical / Nutraceutical Production (manufacturing and/or packaging).

(Experience in Metered dose inhaler (Metered Dose Inhalers (Inhalation) or Derma (Topicals) production would be preferred).

• Familiar with Good documentation and correction practices.
• Should have handful experience of GMP document record execution like batch records, logbooks, protocols, etc.
• Knowledge of deviations/incidents and CAPA.
• A familiarity with cGMPS, CFRs, OSHA and FDA regulations

Compensation

Min

USD $17.00/Hr.

Max

USD $21.00/Hr.

Physical Requirements

WAREHOUSE OR PRODUCTION POSITION - While performing the duties of this job the employee is required to: Regularly lift and/or move objects 10-50lbs Frequently required to stand, walk, stoop, kneel, crouch or crawl Occasionally required to sit and climb or balance Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust and focus The worker is subject to environmental conditions. Protection from weather conditions but not necessarily from temperature changes The worker is subject to both environmental conditions. Activities occur inside and outside Medium work Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects.

Additional Physical Requirements

Standing 4-8 HoursSitting 1-4 HoursWalking 1-4 Hours

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.