Associate I/II, Manufacturing Operator (1st Shift 6:00 am to 2:30 pm)

Role Summary

Associate I/II, Manufacturing Operator (1st Shift 6:00 am to 2:30 pm) responsible for executing quality and manufacturing procedures to meet production demands and regulatory requirements. Duties include on-time manufacture of intermediate, semi-finished and finished pharmaceutical products that meet quality standards, assisting with equipment specifications, SOPs, and manufacturing techniques, and supporting equipment maintenance and calibration.

Responsibilities

• Works on assignments that are semi-routine in nature where some judgment is required in resolving problems and making routine recommendations. Exercises some judgment within defined practices and policies in evaluating criteria for obtaining results.
• May provide guidance on assignments to other lower-level personnel.
• Execute manufacturing operations as required by Manufacturing Records according to Current Good Manufacturing Practices and Standard Operating Procedures in a clean room environment
• Performs manufacturing area and equipment setup, cleanup and teardown and sanitization with supervision
• Operates manufacturing production equipment, under supervision, as required by Manufacturing Records and Standard Operating Procedures
• Performs in-process inspection and testing, under supervision, as required by Manufacturing Records and Standard Operating Procedures
• Accurately and completely documents manufacturing activities in appropriate Manufacturing Records, Controlled Forms Product Container Labels and Logbooks
• Verifies and documents manufacturing steps performed by other Manufacturing Associates as correct in Manufacturing Records and / or Logbooks
• Responsible for observing all Company, Health, Safety and Environmental guidelines
• Fully qualified and able to operate approximately 50% of manufacturing equipment.

Qualifications

• Required: High School/GED with minimum of (0-3 years Associate I) or (3 to 5 years Associate II) related experience or the equivalent combination of experience and training.
• Required: Must be willing and able to receive medical clearance to wear a respirator (i.e., Powered Air Purifying Respirator) for entire working shift.
• Required: Must be physically able to gown and de-gown (including the use of a decontamination fogging shower) in up to three layers of clean room and potent compound facility gowning (i.e., Tyvek jumpsuit).

Education

• High School/GED (as above in Qualifications)