Process Operator

Axelon Services Corporation

Davie, FL

JOB DETAILS
SKILLS
Biotech and Pharmaceutical, Communication Skills, Corporate Communications, Current Good Manufacturing Practice (cGMP), Data Processing, English Language, FDA (Food and Drug Administration), Federal Laws and Regulations, GMP (Good Manufacturing Practices), High School Diploma, Identify Issues, Manufacturing, Manufacturing/Industrial Processes, Mathematics, Physical Demands, Process Improvement, Quality Monitoring, Reconciliation, Record Keeping, Regulations, Regulatory Requirements, Safety Compliance, Safety Process, Safety/Work Safety, Standard Operating Procedures (SOP), State Laws and Regulations, Time Management
LOCATION
Davie, FL
POSTED
4 days ago


Location: Davie, FL
Shift Schedule: Monday – Friday 10:00pm – 6:30am EST (30-minute break at 1am and 4am)




Responsibilities:

  • Carry out responsibilities in accordance with the organization’s policies, procedures, and state, federal, and local laws.
  • Report process or equipment problems to supervisor; perform minor or basic troubleshooting.
  • Ensure batch records, equipment log books, and other relevant records are current; perform batch record reconciliation.
  • Maintain records of manufacturing process by recording data on batch record.
  • Set-up and operate equipment for processing operations.
  • Communicate effectively with previous and incoming shift operator and related personnel.
  • Clean and maintain processing rooms and equipment.
  • Monitor process and equipment and make necessary adjustments to maintain batch record specifications.
  • Monitor product quality.
  • Perform reconciliations.
  • Conduct in-process testing.
  • Check and adjust calculations.
  • Check/review labels and batch records for accuracy.
  • Suggest improvements in methodology or process.
  • Understand concept of delivery/on-time production.
  • Follow established department SOP’s and batch record instructions.
  • Comply with all company policies and procedures, including safety rules and regulations.
  • Perform related duties as assigned.


Requirements:

  • High School Diploma or equivalent.
  • Fluent in English speaking, writing, and reading.
  • Good attitude.
  • Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
  • Basic math skills.
  • Comply with all company safety rules and regulations.


Preferred Skills:

  • GMP experience.
  • Manufacturing experience is a plus and pharmaceutical experience is a plus.
  • Proper English grammar and punctuation.


Physical Requirements:

  • Regular and/or routine periods of sitting, standing, walking, stooping, reaching, and climbing.
  • Visual acuity to monitor and/or read.
  • Communicating orally with company management, peers, and co-workers.
  • Occasional periods of moving and lifting a minimum of 35 pounds.
  • Work is performed in a manufacturing environment with noise levels varying from moderate to loud depending upon machinery usage.
  • Work performed may require the use of a respirator and incumbents may be subject to a Pulmonary Function Test (PFT) to determine eligibility for fit-testing.

About the Company

A

Axelon Services Corporation