Job Description

Job Title: Process Operator

Managers Location: 117 333 Phoenixville Pike 23-2851924 Malvern PA 19355

Duration: 6 months Contract (TEMP TO HIRE)

Description/Comment: PAY - $22 - $24 - - TEMP TO HIRE - SHIFT - 1PM - 11:30PM - MAY START TRAINING ON 1ST SHIFT - MUST HAVES - LIFT 40 + LBS, ABLE TO WEAR AIR SUIT, SOME GMP PREFERRED, DEPENDABLE, BASIC MATH SKILLS.

The Process Operator micronize\mills client provided material including both active pharmaceutical ingredients and excipients as per Malvern procedures and policies, client instructions and cGMP guidelines. Consistently models values and leadership behaviors in all interactions.

Operator I Functions :

• Perform entry-level micronization and milling of both hazardous and non-hazardous pharmaceutical actives and excipients.
• Set up, operate equipment, and monitor production processes.
• Report production on batch records following good documentation procedures (GDPs).
• Work in a regulated environment with adherence to standard operating procedures and policies.
• Adhere to cGMP standards.
• Identify and communicate non-routine events, deviations, and GMP deficiencies to supervisor promptly.
• Clean the entire processing area and processing equipment.
• Produce thorough, clear, and consistent documentation in compliance with Quality Standards (Attributable, Legible, Contemporaneous, Original, and Accurate).
• Demonstrate willingness to accept change, learn, and work with new processes.
• Stop and ask questions or suggest improvements when something is unclear.
• Participate in shift change meetings, site/team meetings, sending/receiving emails, offering suggestions for improvements, and participating in projects.
• This is a site-based position.
• Strive to achieve First Time Right (FTR) as a key performance indicator (KPI) in order to meet our yearly targets.
• Remain current with Compliance Wire and other site training.
• Perform all other duties assigned by management

Measures of Performance:

• Adherence to safety and quality procedures

• Product quality, throughput and final yields

• Excellent attendance, punctuality, and dependability

• Operators’ work ethic and general attitude as it pertains to the daily operations of the facility

III. Position Requirements:

Education or Equivalent:

High School Diploma or GED

Experience:

• Must be dependable, ready/eager to learn and able to meet the physical requirements of the job.

• Prior manufacturing experience and work in a regulated environment preferred.

• Ability to work weekday and weekend OT a plus.

Knowledge/Skills Requirements:

Technical Skills/Knowledge

• Communication Skills Oral and Written

• Basic Math Skills, interpretation

• Potential limited exposure to heath & physically hazardous chemicals.

• Personal protective equipment, including gloves, a respirator hood, safety glasses, safety shoes and other Personal Protective Equipment is provided and is required to be worn in designated areas.

• Prior Production Experience preferred

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