Operations Associate

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.