Manufacturing Specialist Investigation Lead
Manufacturing Specialist Investigation Lead
Posted on :
26-10-2024
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1 Vacancy
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Job Description
About PSC Biotech
Who we are
PSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloudbased software solutions for Quality Management and Regulatory Inspections pharmaceuticals contract manufacturing professionals and metrology services to our clients.
PSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloudbased software solutions for Quality Management and Regulatory Inspections pharmaceuticals contract manufacturing professionals and metrology services to our clients.
Take your Career to a new Level
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of likeminded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diversecultural work setting.
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of likeminded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diversecultural work setting.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client s expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.
Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client s expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.
Description:
The Manufacturing Specialist (Investigation Lead) will be primarily responsible for leading investigations for fill/finish/inspection and packaging deviations. Specialists will also be involved in applying process quality compliance and analytical knowledge to complete the following:
- Manage deviation investigations including establishing investigation teams leading root cause analysis development of CAPAs completing product impact assessments and writing comprehensive compliant documentation of all findings.
- Clear and concise technical writing of complex investigations.
- Drive improvements to the investigation process.
- Present investigations to regulatory inspectors and internal auditors.
- Clearly communicate investigation progress to impacted areas and leadership.
- Coordinate and lead crossfunctional teams through complex investigations and complete tasks onschedule.
- Project management of the investigations end to end.
- Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
- Build effective relationships across functions.
- Navigate through ambiguity and provide a structured problemsolving approach.
- Able to apply inductive and deductive reasoning in the investigation process.
Requirements
Qualifications:
- Bachelors Degree in Science or Engineering and 5 years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development engineering quality) OR.
- * Associates Degree in Science or Engineering and 8 years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development engineering quality).
- * 10 years directly related experience in a biotech/pharma manufacturing or manufacturing environment
- Detailed technical understanding of fill/finish operations.
- Experience with compliance problemsolving root cause analysis critical thinking project management and quality systems.
- Experience leading complex investigations.
- Experience participating in and leading crossfunctional teams.
- Experience in managing multiple competing priorities in a fastpaced environment.
- Experience presenting to inspectors during regulatory inspections and internal audits.
- Excellent technical writing.
- Excellent presentation and communication skills ability to communicate and collaborate with technical and management staff.
- Ability to be flexible and manage change.
#LIEL1
Knowledge/Skills: Strong Project Management and organizational skills, including ability to follow assignments through to completion. Excellent verbal and written communication skills: Strong Technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good Presentation skills. Escalate issues professionally and in a timely manner. Ensures compliance within regulatory environment. Demonstrated ability to work independently and deliver right first-time results under minimal direction. Experience participating in and leading cross-functional teams. Experience in managing multiple, competing priorities in a fast-paced environment. Relevant Experience: Bachelor s degree in a Science or Engineering discipline. 3+ years of experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organization. Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products an advantage. #LI-XA1
Employment Type
Full Time
Key Skills
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