Process Operator

4 weeks ago

Malvern, United States Apex Systems Full time

Apex Systems is looking for Process Operators in the Malvern, PA area

**For immediate consideration please send an updated copy of your resume to Megan at mmantlo@apexsystems.com with “Process Operator Malvern, PA” in the subject line**


Job Title: Process Operator

Rate: $23/hr

Duration: Starting at 6 months with possible conversion

Location: Malvern, PA 19355 (100% onsite)

Schedule: Monday - Thursday 1PM - 11:30PM


Summary: Join our dynamic team as a Process Operator, where you’ll play a crucial role in micronizing and milling client-provided materials, including both active pharmaceutical ingredients and excipients. You’ll follow company procedures, client instructions, and cGMP guidelines to ensure high-quality production.


Responsibilities:

  • Micronization and Milling: Handle both hazardous and non-hazardous pharmaceutical actives and excipients.
  • Equipment Operation: Set up, operate, and monitor production equipment, ensuring accurate reporting on batch records in line with good documentation procedures (GDPs).
  • Documentation Review: Ensure completeness, clarity, and accuracy of batch records, SOPs, and logbooks, and submit necessary edits for revision.
  • Regulatory Compliance: Work in a regulated environment, adhering to standard operating procedures and cGMP guidelines. Report non-routine events, deviations, and GMP deficiencies promptly.
  • Cleaning and Maintenance: Maintain cleanliness of the processing area and equipment.
  • Quality Documentation: Produce thorough, clear, and consistent documentation in compliance with Quality Standards (Attributable, Legible, Contemporaneous, Original, and Accurate).
  • Continuous Improvement: Ask questions and suggest improvements when processes are unclear. Participate in shift change meetings, team meetings, and projects, offering suggestions for enhancements.
  • Training and Development: Stay current with ComplianceWire and other site training. Strive for First Time Right in all tasks.


Qualifications:

  • Education: High School Diploma or GED.
  • Dependability: Must be reliable, eager to learn, and able to meet the physical demands of the job.
  • Experience: Prior manufacturing experience and work in a regulated environment preferred.
  • Flexibility: Ability to work weekday and weekend overtime is a plus. Willingness to accept change and learn new processes.
  • Safety Awareness: Potential limited exposure to health and physically hazardous chemicals.
  • Personal Protective Equipment: Provided and required in designated areas, including gloves, a respirator hood, safety glasses, and safety shoes.
  • Physical Requirements:
  • Physical strength, stamina, and dexterity while wearing a fully enclosed air suit (preferred).
  • Ability to lift or move items up to 44 lbs. (20kg) individually, or with a two-person lift between 45 lbs and 76 lbs. (35kg). Items over 77 lbs require a lift assistance device (preferred).
  • Ability to work safely with high potency active pharmaceutical ingredients (HPAPI) and novel compounds of unknown potency and toxicity (preferred).
  • Ability to perform moderate physical labor, including lifting, climbing, bending, crouching, reaching, and twisting (preferred).
  • Ability to stand or walk for up to 8 hours per day (preferred).


Why Join Us?

  • Innovative Environment: Be part of a team that values innovation and continuous improvement.
  • Professional Growth: Opportunities for training and development to enhance your skills.
  • Collaborative Culture: Work in a supportive and collaborative environment where your contributions are valued.


Ready to take the next step in your career? Apply now and become a key player in our mission to deliver high-quality pharmaceutical products


**For immediate consideration please send an updated copy of your resume to Megan at mmantlo@apexsystems.com with “Process Operator Malvern, PA” in the subject line**

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