Operations Associate

Granules Pharmaceuticals, Inc.; Chantilly (VA); On-site; USD 50,000 - 65,000; Full time

Job summary

Granules Pharmaceuticals, Inc. in Chantilly, VA is seeking an Operations Associate to support warehouse and manufacturing processes, uphold cGMP standards, maintain accurate documentation, and drive process optimization.

You will manage SAP master data, participate in automation initiatives and GMP equipment validation, ensure data integrity in reports, and collaborate across teams to sustain regulatory compliance and efficient production.

Qualifications

• Bachelor's degree required; 2+ years in a cGMP-regulated environment preferred.
• Experience writing and maintaining cGMP documentation.
• Experience with materials receipt and storage; strong data analysis skills.

Responsibilities

• Maintain awareness of new data analysis methods for inventory control.
• Prepare cycle count reports and publish findings.
• Document changes and issues in the change control system.
• Create and manage SAP master data (BOM, Material Master, Production versions, etc.).
• Assist in SAP PP/MM modules and data management tasks.
• Support automation initiatives and participate in GMP equipment validation.

Skills

Data analysis

Inventory control

Cross-functional collaboration

Communication skills

Documentation

DEA compliance

cGMP compliance

Education

Bachelor's degree in Healthcare informatics or scientific discipline

Tools

SAP

BMRAM

Job description

Description

The

Job Type
Full-time

Description

The Operations Associate plays a key role in ensuring the smooth and compliant operation of both warehouse and manufacturing processes. This position is responsible for a wide range of duties, including maintaining cGMP standards, supporting material movement and inventory control, and overseeing the preparation and review of essential documentation. The associate will also actively engage with SAP for master data management, assist in the implementation of automation initiatives, and participate in the validation of GMP equipment. Additionally, this role involves collaboration across teams, ensuring the accuracy of reports, managing operational improvements, and maintaining rigorous adherence to regulatory requirements. With a focus on precision, process optimization, and compliance, the Operations Associate will contribute to the overall efficiency and quality of manufacturing operations. Personnel should perform function in accordance with cGMP and related company SOP's, state, federal and local laws as applicable. This person should be knowledgeable of cGMP requirements, FDA regulations and ICH guidelines.

Responsibilities

• Maintain awareness of new and emerging computational methods and technologies (Data analysis) for inventory control.
• Participate in the preparation of cycle count reports and periodic publication.
• Document all changes, modifications, or issues in the database using the change control program.
• Creating and maintaining the master data in SAP (BOM master, Resource master, Production version, Material master, Inspection plan etc.).
• Engage as a user in managing SAP in inventory control.
• Develop skills and provide user support for PP/MM modules in SAP.
• Use computer sequential process for querying databases.
• Create data management or error checking procedures including corrective actions
• Actively participate in implementing and enhancing automation in manufacturing activities.
• Participate in Computer system validation activities for the equipment involved in GMP (IQ/OQ/PQ).
• Analyze data reports like stock statement, production report, consumption report and shipments etc.
• Manage master data by creating new records, editing the records and generating reports in Blue Mountain Regulatory Asset Manager (BMRAM) software.
• Assist in pharmaceutical environment handling DEA materials and Data entry and perform activities for various materials received.
• Write, revise, and review of SOP's that are related to job functions.
• Creates purchase requisitions for the acquisition of materials for manufacturing
• Participating in operational, safety, quality and management initiatives.
• Perform Any other activity as assigned by the Supervisor.

Requirements

• A background in cGMP compliance and DEA compliance within the pharmaceutical manufacturing industry is required.
• Experience in writing and maintaining cGMP documentation.
• Experience in materials receipt and storage.
• Ability to analyze data/information and to assess and resolve complex issues, as required.
• Good verbal and written communication skills are required.
• Ability to work and communicate with cross-functional teams.
• Ability to manage multiple priorities and re-prioritize tasks, as required.
• Flexible and able to adapt to company growth and evolving responsibilities
• Strong attention to detail and excellent organization.

Education/Experience

• Degree: Minimum Bachelor's degree; a degree in Healthcare informatics, or any scientific discipline.
• Experience: 2+ years of experience in a cGMP-regulated environment, with experience in pharmaceutical manufacturing highly preferred.

Disclaimer

The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Salary Description

$50,000 - $65,000/Year