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 3 years ago – Accepting applications
Job Detail
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Offerd Salary $ 25 - $ 45
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Required Position 2-4 hires
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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