Manufacturing - Process Operator I

Ampcus Inc.•Malvern, PA

11d•Onsite

About The Position

The Process Operator is responsible for micronizing and milling client-provided materials, including both active pharmaceutical ingredients and excipients, in accordance with client Malvern procedures, client instructions, and cGMP guidelines. The role requires consistent modeling of client values and leadership behaviors.

Requirements

High School Diploma or GED.
Must be dependable, ready/eager to learn and able to meet the physical requirements of the job.
Ability to work safely with high potency active pharmaceutical ingredients (HPAPI).
Ability to perform moderate physical labor including lifting, climbing, bending, crouching, reaching, and twisting.
Ability to stand or walk for up to 8 hours per day and work in loud environments with hearing protection.
Technical Skills/Knowledge including Communication Skills, Basic Math Skills, and interpretation.

Nice To Haves

Prior manufacturing experience and work in a regulated environment preferred.
Ability to work weekday and weekend overtime a plus.

Responsibilities

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.
Strive to achieve First Time Right (FTR) as a key performance indicator (KPI) in order to meet our yearly targets.