Manufacturing Specialist

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.

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.

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.

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.

Requirements

Role responsibilities:

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

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

#LIKV1

Role responsibilities: 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 cross-functional teams through complex investigations, and complete tasks on-schedule. 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 problem-solving approach. Able to apply inductive and deductive reasoning in the investigation process Qualifications: Bachelor 's 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 * Associate 's 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, problem-solving, root cause analysis, critical thinking, project management, and quality systems. Experience leading complex investigations Experience participating in and leading cross-functional teams Experience in managing multiple, competing priorities in a fast-paced 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 #LI-KV1