Plant Quality Assurance Associate

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 point 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.

Description:

Plant Quality Assurance (PQA) Associate

24/7, 12hr shift role - Eye Test Required for this position - Inspection Role.

Overview:

The Plant Quality Assurance (PQA) Snr Associate will report to the QA Manager and will be a core member of the site Quality Assurance team.

The PQA Snr Associate will serve as Quality point of contact for manufacturing operations.

The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, PQA Snr Associates may be asked to carry out additional work functions to support site continuous improvement activities.

This is a 24/7 shift role required to support manufacturing operations.

Preferred Qualifications & Experience:

Excellent written and verbal communication skills.

Experience working with dynamic cross-functional teams and proven abilities in decision making.

Strong organizational skills, including ability to follow assignments through to completion.

Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations.

Experience working in aseptic operations, protein formulation, vial and syringe filling, vial and syringe inspection.

Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.

Key Responsibilities:

Perform all activities in compliance with Amgen safety standards and standard operating procedures.

o Observe and provide real-time quality oversight and support for manufacturing on the floor.

o Perform purposeful presence on the floor audits.

o Perform manual visual inspection AQL audits of vials and syringes.

o Perform QA reserve sample inspections as part of the annual reserve inspection program and in support of customer complaint investigations

o Certification of defect panels.

o Provide quality support for triage and investigation of all classes of deviation events.

o Review/approve deviations for closure ensuring compliance with appropriate standards.

o Review/approve production batch records, and associated documentation in preparation for qualified person disposition activities.

o Provides training and advice to staff in order for them to perform their desired functions.

o Write, review and approve standard operating procedures in accordance with Amgen policies.

o Support continuous improvement and operational excellence initiatives

o Any other tasks/projects assigned as per manager s request.

Requirements

Basic Qualifications & Experience:

o University degree. Engineering or Science related discipline preferred.

o Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.

Preferred Qualifications & Experience:

o Excellent written and verbal communication skills.

o Experience working with dynamic cross-functional teams and proven abilities in decision making.

o Strong organizational skills, including ability to follow assignments through to completion.

o Demonstrated ability in problem solving and experience in managing Root Cause Analysis /Deviation investigations.

o Experience working in aseptic operations, protein formulation, vial and syringe filling.

o Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.

#LI-DM1

Basic Qualifications & Experience: o University degree. Engineering or Science related discipline preferred. o Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role. Preferred Qualifications & Experience: o Excellent written and verbal communication skills. o Experience working with dynamic cross-functional teams and proven abilities in decision making. o Strong organizational skills, including ability to follow assignments through to completion. o Demonstrated ability in problem solving and experience in managing Root Cause Analysis /Deviation investigations. o Experience working in aseptic operations, protein formulation, vial and syringe filling. o Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues. #LI-DM1