Associate II, Manufacturing Operator (12 Hour Shift - Every Other Wed, Every Thurs, Fri & Sat)

Role Summary

Associate II, Manufacturing Operator role responsible for executing quality and manufacturing procedures to meet production demands and regulatory requirements. Responsibilities include on-time manufacture of intermediate, semi-finished and finished pharmaceutical products that meet quality standards. Supports establishing equipment operating specifications, standard operating procedures, and improving manufacturing techniques, and assists with equipment maintenance, calibration and resolving technical issues. Schedule: Every Other Wednesday; every Thursday, Friday and Saturday from 6:00 am to 6:30 pm, with a 5% shift differential.

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 2–4 years 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).

Skills

• Knowledge of Current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs).
• Strong documentation and record-keeping abilities in Manufacturing Records, labels and logbooks.
• Ability to operate and troubleshoot manufacturing equipment in a clean room environment; perform setup, teardown, sanitization under supervision.
• In-process inspection and testing under supervision.
• Commitment to health, safety and environmental guidelines.
• Ability to operate approximately 50% of manufacturing equipment.

Education

• High School Diploma or GED.