Operations Associate

About the Role

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 maintaining cGMP standards, supporting material movement and inventory control, and overseeing the preparation and review of essential documentation. The associate will also engage with SAP for master data management, assist in automation initiatives, and participate in the validation of GMP equipment. This role involves collaboration across teams, ensuring accuracy of reports, managing operational improvements, and maintaining rigorous adherence to regulatory requirements.

Personnel should perform functions in accordance with cGMP and related company SOPs, 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.
• Create and maintain master data in SAP (BOM master, Resource master, Production version, Material master, Inspection plan, etc.).
• Engage as a user in managing SAP for 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 GMP equipment (IQ/OQ/PQ).
• Analyze data reports such as stock statements, production reports, consumption reports, and shipments.
• Manage master data by creating new records, editing records, and generating reports in Blue Mountain Regulatory Asset Manager (BMRAM) software.
• Assist in pharmaceutical environment handling DEA materials, data entry, and perform activities for various materials received.
• Write, revise, and review SOPs related to job functions.
• Create purchase requisitions for the acquisition of materials for manufacturing.
• Participate 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 assess and resolve complex issues.
• Good verbal and written communication skills.
• 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 skills.

Qualifications

Education: 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.

Pay

$50,000 – $65,000/year