Onsite
Temp to Hire
Shift: Monday - Friday | 8:00am - 5:00pm
Job Description:
The Process Operator micronize\mills client provided material including both active pharmaceutical
ingredients and excipients as per Client's Micron Technologies procedures and policies, client instructions and cGMP guidelines.
Essential Functions:
- Micronization and milling of both hazardous and non-hazardous pharmaceutical actives and excipients.
- Set up, operate equipment, and monitor production processes and report production on batch records in accordance with good documentation procedures (GDPs)
- Review documentation (batch records, SOPs, Logbooks) for completeness, clarity, accuracy and submit edits to documents for revision as required.
- Ability to work in a regulated environment with adherence to standard operating procedures
- Capable of reading and following defined SOPs and policies and executes tasks accordingly.
- Work in accordance with cGMP. Identify and communicate non-routine events, deviations and GMP deficiencies to supervisor in a timely manner.
- Cleaning of the entire processing area and processing equipment.
- Produce thorough, clear & consistence documentation in compliance with Quality Standards (Attributable, Legible, Contemporaneous, Original and Accurate)
- Willingness to accept change, learn, and work with new processes.
- Stops and asks questions or suggests improvements when something is unclear.
- Participate in shift change meetings, site/team meetings, sending/receiving emails, offering suggestions for improvements, and participating in projects.
- Strives for First Time Right
- Remains current with CompliaceWire and other site training
- Carry out all duties in line with the procedures and policies set forth by Client's Micron
- This is a site-based position.
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
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
- Organizational Skills
- Detail Orientation
- Communication Skills Oral and Written
- Basic Math Skills, interpretation
- Ability to Multi-task and prioritize
- Willingness to accept change, learn, and work with new processes.
- 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
Physical Requirements/Work Environment:
- Physical strength, stamina and dexterity while wearing fully enclosed air suite
- Employees 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 novel 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 wear a respirator hood and pass the required
Job Type: Full-time
Pay: $22.00 per hour
Expected hours: 40 per week
Benefits:
- Dental insurance
- Health insurance
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Ability to Relocate:
- Malvern, PA 19355: Relocate before starting work (Required)
Work Location: In person