Senior QA 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:

Overview:

• The Quality Assurance (QA) Snr Associate will typically report to a Snr QA Manager and is a core member of the site Quality Assurance team.
  
• The QA Snr Associate will serve as Quality point of contact for Packaging operations, as well as support the complaints function.
  
• The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, QA Snr Associates may be asked to carry out additional work functions to support site continuous improvement activities.
  

A variety of shift patterns may be required to support packaging operations, including but not limited to day shift, 16/5 shift, 24/5 shift. Weekend work may also be required.

Key Responsibilities:

Perform all activities in compliance with **** safety standards and SOPs.

Observe and provide real-time Quality oversight and support for Packaging unit operations.

Perform purposeful presence Quality walks on the shop floor to ensure permanent inspection readiness.

Participates in Customer complaint investigations.

Perform Packaging Quality audits on every Packed lot.

Provide Quality support for triage of atypical events.

Quality oversight of minor investigations, including review and approval of Deviations for closure ensuring compliance with appropriate documentation.

Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.

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

Write, review and approve Standard Operating Procedures in accordance with **** Policies.

Support continuous improvement and Operational Excellence initiatives.

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

Requirements

Basic Qualifications & Experience:

University degree. Engineering or Science related discipline preferred.

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:

Excellent written and verbal communication skills

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

Fluency in SAP, Trackwise, Excel, Teams, etc

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

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

Experience working with combination products or devices in packaging-related or complaint-handling activities

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

Operational Excellence experience

#LI-BR1

Basic Qualifications & Experience: University degree. Engineering or Science related discipline preferred. 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: Excellent written and verbal communication skills Experience working with dynamic cross-functional teams and proven abilities in decision making Fluency in SAP, Trackwise, Excel, Teams, etc Strong organizational skills, including ability to follow assignments through to completion Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations Experience working with combination products or devices in packaging-related or complaint-handling activities Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues Operational Excellence experience #LI-BR1