Title:  Operator, Sterile

JOB PURPOSE:

To set up, operate and clean equipment in moderately complex production areas as well as ensure products follow appropriate procedures in a clean and safe work environment in order to meet all cGMP, FDA, DEA, OSHA and other applicable regulations.

KEY ACCOUNTABILITIES:

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/equipment setup, cleaning and changeover activities that require the use of hand tools, removing and replacing machine parts, adjusting instrumental devices and cleaning parts in 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.
• 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 Qualifications: Diploma in Pharmacy, Manufacturing or related fields.

Minimum Experience: 0-3 years relevant experience.