Drug Product Manufacturing Specialist

  • Contractor
  • Full-Time
  • Remote
  • Splintpharma
  • Prefferd visa: OPT, CPT, F1, H4, L2, Have H1 Visa, Need H1 Visa, EAD, TN Permit Holder, Green Card Holder, US Citizen
  • Posted 2 years ago – Accepting applications
Job Detail
  • Offerd Salary $ 25 - $ 45
  • Required Position 2-4 hires
  • Experience 0-3 Years Required
Job Description

Responsibilities include but are not limited to:

  • Serve as a manufacturing technical SME on a cross functional special project
    • Acts as Manufacturing Record Owner of a subset of quality records, including Deviation, CAPA and Change Control
    • Drivethese quality records to successful closurein partnership with cross functional SMEs and Record Owners (i.e. Quality, Regulatory)
    • Conduct and document detailed investigations independently
    • Lead and support continuous improvements of manufacturing processes to enhance efficiencyand compliance
  • Provide technical support of GMP manufacturing operations and staff.
    • Author, revise, and review GMP supporting documentation (SOP’s, Batch Records, Forms, etc.)
  • Support internal and external audits and inspections as needed
  • Perform other duties as assigned

 

Minimum Requirements:

  • Bachelor's degree in engineering or life science
  • Minimum 3 years' experience in GMPbiologics and/or vaccine Drug Productmanufacturing
  • Demonstrates interpersonal, technical aptitude, and problem-solving skills
  • Knowledgeable in systematic root cause analysis methodologies and their application of these methodologies 
  • Knowledge and expertise in principles and practice of current Good Manufacturing Practices (cGMPs)
  • Excellent verbal, written, and interpersonal communication skills
  • Proficiency in Microsoft products, including Microsoft Office applications, Microsoft Teams, Microsoft SharePoint, PowerBI
  • Experience with Quality Management Systems & statistical analyses is preferred
Job Requirement

Responsibilities include but are not limited to:

  • Serve as a manufacturing technical SME on a cross functional special project
    • Acts as Manufacturing Record Owner of a subset of quality records, including Deviation, CAPA and Change Control
    • Drivethese quality records to successful closurein partnership with cross functional SMEs and Record Owners (i.e. Quality, Regulatory)
    • Conduct and document detailed investigations independently
    • Lead and support continuous improvements of manufacturing processes to enhance efficiencyand compliance
  • Provide technical support of GMP manufacturing operations and staff.
    • Author, revise, and review GMP supporting documentation (SOP’s, Batch Records, Forms, etc.)
  • Support internal and external audits and inspections as needed
  • Perform other duties as assigned

 

Minimum Requirements:

  • Bachelor's degree in engineering or life science
  • Minimum 3 years' experience in GMPbiologics and/or vaccine Drug Productmanufacturing
  • Demonstrates interpersonal, technical aptitude, and problem-solving skills
  • Knowledgeable in systematic root cause analysis methodologies and their application of these methodologies 
  • Knowledge and expertise in principles and practice of current Good Manufacturing Practices (cGMPs)
  • Excellent verbal, written, and interpersonal communication skills
  • Proficiency in Microsoft products, including Microsoft Office applications, Microsoft Teams, Microsoft SharePoint, PowerBI
  • Experience with Quality Management Systems & statistical analyses is preferred
Required skills