QC Senior Associate
2 weeks ago
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 cloud-based 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 points which includes the opportunity to work with the most talented cohort of like-minded 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 diverse-cultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house 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.
QC Senior Associate
Overview:
· QC Systems Senior Associate Investigations is a key member of the QC Systems team. They provide support to the QC function for all activities within client Quality System associated with QC Deviation Investigations, CAPA records, Analytical Results Assessments (ARA) and Change Controls.
· The successful candidate will own and manage the end-to-end life cycle of Quality records on behalf of Quality Control. The role has a strong focus on technical writing and problem-solving including Root Cause Analysis and 5 Why methodologies.
· The role may involve carrying out additional work functions that are not described in this specification but are required as per business needs.
Requirements
Specific Duties/ Scope:
· Triage Management
· Quality Record owner
· Technical writing for investigations
· Ensure timely closure of Quality Records
· SME for Root Cause Analysis and 5 Why methodologies
· Development of robust CAPA and CAPA Effectiveness Verification in conjunction with area SMEs
· Trend Analysis of QC Quality records
· Monthly Metrics Management and Reporting
· Participate in cross functional Investigations Teams
· Lead Continuous Improvement Initiatives
· Contribute to success of QC Goals
· Support NPI/ Lot Release / Stability linked to Quality Records
· Participate in Regulatory Inspections
· Ownership of Change Controls Key Values and Competencies:
· Work in Teams; Ensure Quality; Be Science Based; Collaborate, Communicate and Be Accountable
· Ability to work through Complex Problems
· Excellent verbal and written communication skills including technical writing, presentation, and facilitation skills.
· Ability to work in a fast-paced environment with changing priorities.
· Comfortable working under minimal direction Knowledge and Experience
· Hold a third level qualification in a science related discipline.
· Have a minimum of 4 years’ experience in Biopharmaceutical/ Pharmaceutical industries or 2 years in a similar investigator role.
· Experience owning Quality Records e.g. Deviation Records, CAPA, ARA and Change Controls advantageous.
· Possess key competencies to include planning/organization, problem solving, excellent verbal and written communication, teamwork, flexibility, and adaptability.
#LI-KV1
Requirements
Specific Duties/ Scope: · Triage Management · Quality Record owner · Technical writing for investigations · Ensure timely closure of Quality Records · SME for Root Cause Analysis and 5 Why methodologies · Development of robust CAPA and CAPA Effectiveness Verification in conjunction with area SMEs · Trend Analysis of QC Quality records · Monthly Metrics Management and Reporting · Participate in cross functional Investigations Teams · Lead Continuous Improvement Initiatives · Contribute to success of QC Goals · Support NPI/ Lot Release / Stability linked to Quality Records · Participate in Regulatory Inspections · Ownership of Change Controls Key Values and Competencies: · Work in Teams; Ensure Quality; Be Science Based; Collaborate, Communicate and Be Accountable · Ability to work through Complex Problems · Excellent verbal and written communication skills including technical writing, presentation, and facilitation skills. · Ability to work in a fast-paced environment with changing priorities. · Comfortable working under minimal direction Knowledge and Experience · Hold a third level qualification in a science related discipline. · Have a minimum of 4 years’ experience in Biopharmaceutical/ Pharmaceutical industries or 2 years in a similar investigator role. · Experience owning Quality Records e.g. Deviation Records, CAPA, ARA and Change Controls advantageous. · Possess key competencies to include planning/organization, problem solving, excellent verbal and written communication, teamwork, flexibility, and adaptability. #LI-KV1
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