Process Operator

Ampcus Inc.•Malvern, PA

10d•Onsite

About The Position

The Process Operator micronizes/mills client-provided material including both active pharmaceutical ingredients and excipients as per Client Malvern procedures and policies, client instructions, and cGMP guidelines. Consistently models Client 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.

Requirements

Technical Skills/Knowledge
Communication Skills Oral and Written.
Basic Math Skills, interpretation.
Potential limited exposure to health & 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.
Physical strength, stamina, and dexterity while wearing a fully enclosed air suit.
Employees must be able to lift or move items up to 44 lbs. (20kg) individually, or with a two-person lift between 45 lbs and 76 lbs. (35kg). 77 lbs and over with a lift assistance device.
Ability to work safely with high potency active pharmaceutical ingredients (HPAPI) as well as Client compounds of unknown potency and toxicity.
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.
Ability to climb steps/ladders and occasionally work from elevated platforms.
Ability to wear a respirator hood and pass the required respiratory medical exam.
Ability to work in loud environments and wear various types of hearing protection.
Ability to work with chemicals, health/physical hazardous material safely and in compliance with the site safety program.
High School Diploma or GED.
Must be dependable, ready/eager to learn and able to meet the physical requirements of the job.

Nice To Haves

Prior Production Experience preferred.
Prior manufacturing experience and work in a regulated environment preferred.
Ability to work weekday and weekend OT 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.