Manufacturing Associate I

Job Summary

Required Qualifications

• •High School Diploma
• •1-3 years of work experience in mechanically based or similar role
• •Willingness to work extended shifts and a variable schedule when required
• •Flexible individual with good written and verbal communication skills
• •MS Office/Excel tools experience
• •Excellent communication and organizational skills
• •Self-motivated individual with the ability to complete multiple floor activities in an effective and compliant manner
• •Attention to detail with strong mechanical aptitude
• •Positive attitude and strong interpersonal skills
• •Read, write, and verbally communicate in English
• •Strong ability to plan and prioritize complex activities
• •Strong analytical skills to identify risks and prepare balanced decisions
• •Experience in reviewing and creating controlled documents
• •Experience with sterile injectable drugs
• •Familiarity with formulation, filling, primary packaging, and aseptic processing
• •Strong knowledge of aseptic techniques
• •Ensure documentation is complete, reviewed and meets good documentation practices (forms, logbooks, form preps, batch records, etc.)
• •Ensure general knowledge of aseptic techniques and maintain certification for aseptic gowning and demonstrate the ability to perform duties utilizing proper aseptic technique
• •Perform and ensure CIP and SIP operations are performed to prepare equipment
• •Execute manufacturing instructions to perform equipment preparation, compounding, filtration, formulation, and fill activities for aseptic and terminally sterilized products in accordance with SOPs
• •Strong adherence to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes all appropriate production documentation
• •Identifies, escalates, and documents events that deviate from normal operation; participate as needed in investigations. Assist in the introduction of manufacturing schemes into the GMP manufacturing facility
• •Execution of all routine and critical operations as well as commissioning and validation activities, as assigned
• •Perform room sanitization activities to maintain controlled environment conditions

Desired Qualifications

• •1 year of professional experience in an FDA Regulated Pharmaceutical facility preferred
• •Associates Degree in Life Sciences/Liberal Arts field preferred
• •Experience with sterile injectable drugs preferred
• •Familiarity with formulation, filling, primary packaging, and aseptic processing preferred
• •Strong knowledge of aseptic techniques preferred
• •Experience in reviewing and creating controlled documents preferred