Sr. Operator, Compression

Policies, Processes & Procedures :

• Follows all relevant departmental policies, processes, standard operating procedures and instructions so that work is carried out in a controlled and consistent manner.

Day-to-day Operations :

• Follows the day-to-day operations related to own job to ensure continuity of work.

Job Specific Accountabilities :

• Performs line/equipmentsetup, cleaningand changeover activities that require the use of hand tools, removing and replacing machine parts, adjusting instrumental devices and cleaning partsin order to
• Ensure compliance with cGMP, FDA, DEA,OSHA and other applicable regulations.
• Completes appropriate documentation to support process and production procedures including data capture, forms, logbooks, and inventory batch records.
• Ensures all finished products from each vendor manufacturing orders are received properly in order to account for any excess materials.
• Fills out all necessary department forms, logbooks, and records in order to maintain proper filing of information.
• Follows verbal and written procedures in order to correctly operate production equipment and perform processing steps
• Operates one machine or part of the production line under close and direct supervision in order to ensure compliance with set guidelines and meet production targets.
• Cleans production area, equipment, tools, etc., following appropriate company and regulatory procedures and guidelines in order to prepare for the next production run.

Continuous Improvement :

• Contributes to the identification of opportunities for continuous improvement of processes and practices taking into account ‘international best practice’, improvement of business processes, cost reduction and productivity improvement.

Reporting :

• Assists in the preparation of timely and accurate reports of the Manufacturing department to meet company and department requirements, policies and standards.

Safety, Quality & Environment :

• Complies with all relevant safety, quality and environmental management policies, procedures and controls to ensure a healthy and safe work environment.

Related Assignments :

• Performs other related duties or assignments as directed.

QUALIFICATIONS, EXPERIENCE, & SKILLS :

Minimum 2 years of hands on experience operating tablet compression machines in a GMP pharmaceutical manufacturing environment, with practical knowledge of machine setup/changeover, tooling (punches and dies), compression parameters, in-process controls, troubleshooting, cleaning, and documentation.