Associate Specialist Quality Control-Microbiology

About PSC Biotech

Who are we?

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.

Overview:

• We are seeking an Associate Specialist Quality Control to
  provide technical support to the QC Microbiology Lab & operations to ensure
  the continued manufacture and supply of quality pharmaceutical products in
  meeting the priorities of: Compliance, Supply, Strategy and Profit Plan. This
  role is integral to our manufacturing division and requires a high level of
  leadership, initiative, collaboration, and coaching to facilitate the team in
  becoming a high-performance organization. If you are passionate about driving
  continuous improvement and delivering technical excellence, we invite you to
  join our company and make a difference in advancing health solutions.
  
• Experience in supporting operations projects with
  knowledge of regulatory and global compliance requirements. The ideal candidate
  must have the ability to own and manage projects and deliver on required
  timelines.
  

Requirements

Key Responsibilities

• Supporting the environmental control program by trend
  analysis and implementation of appropriate corrective and preventative
  measures.
  
• Supporting and owner of Environmental monitoring risk
  assessments and qualification.
  
• Generation of quarterly and annual trend reports.
  
• Understanding and applying regulatory/compliance and
  compendial requirements to their role together with remaining current on
  upcoming regulatory and compliance changes.
  
• Development and execution of Microbiology test methods
  and project validations.
  
• Troubleshooting of issues which arise during the
  execution of validation studies and routine tests.
  
• Development of training modules.
  
• Microbiology Support to Site Investigations and projects
  relating to environmental monitoring and utilities monitoring.
  
• Driving Continuous Improvement initiatives, including
  lean lab initiatives, method optimization/redevelopment.
  
• Authoring and managing change controls, procedures, test
  methods and deviations.
  
• Result authorization for microbiological samples to
  support batch release.
  
• GLIMS System updates.
  
• Assessing compendial and quality manual updates
  pertaining to the Microbiology Lab & environmental control.
  
• Supporting lab stock management and financial control as
  required.
  
• Interpreting customer needs, assessing requirements, and
  identifying solutions to non-standard requests.
  
• Making decisions within guidelines and policies which
  impact microbiology projects.
  
• Ensuring highest safety standards.
  
• Performing other duties as assigned.
  

Qualifications:

Required

• Bachelor’s degree in Microbiology, Biology,
  Biotechnology, Pharmaceutical Science, or a related Life Sciences field.
  
• Minimum 3 years of hands-on experience in
  microbiology/QC, specifically in environmental monitoring and utilities
  monitoring, supporting site projects, trending, risk assessments, and data
  analysis.
  
• Ability to author procedures, change controls,
  deviations, reports, and work in line with regulatory/compendial requirements.
  
• Strong troubleshooting, decision-making, and ability to
  drive improvements such as lean lab initiatives and method optimization.
  
• Strong microbiology background and strong understanding
  of aseptic processing, environmental monitoring programs, and contamination
  control in sterile manufacturing.
  
• Experience in a GMP QC laboratory with knowledge of
  regulatory expectations.
  
• Familiarity with ALCOA(+) data integrity principles,
  electronic laboratory systems, and controlled documentation.
  
• Entry- to early-career level with growing technical
  competence; able to perform routine tasks with limited discretion.
  

Preferred:

• Experience with problem solving, decision making,
  scheduling of laboratory testing/tasks