The Role
Performs microbiological and environmental monitoring testing for product release in a cGMP pharmaceutical environment. Responsibilities include sample testing, data review, LIMS documentation, trend reporting, method qualification and validation, contamination investigations, equipment maintenance, SOP updates, audit support, analyst training, sample lifecycle management, and laboratory inventory coordination. The role also supports continuous improvement, process compliance, safety, and manufacturing operations.
Summary Generated by Built In
Purpose
- Part of the Micro/EM Team responsible for the following:
- Performance of
testing of EM / product stream samples to meet product release timelines and in
accordance with cGMP regulations and Roche/Genentech standards.
- Support
manufacturing operations by timely completion of testing and disposition.
- Continuous
improvement of processes and technology, in collaboration with ASAT, to drive right
first time and efficiencies.
- Qualification and
validation of test methods.
- Supporting
investigations of microbial contamination in production processes, classified
environments, and critical utility systems.
- Ensuring test
methods and data are generated in a compliant manner following cGMPs.
Key
Responsibilities
- Testing and review of routine and non-routine environmental, raw material, product related samples in accordance to the Standard Operating Procedures (SOP) and Test Methods (TM).
- Perform EM which includes HVAC / BSC / HLFH / VLFH sampling, fingertips monitoring, compressed gases and water / clean steam sampling in accordance to cGMP procedures when required.
- Documentation and review of results in the Laboratory Information Management System (LIMS) and/or documents in accordance with cGMP Procedures.
- Prepare EM reports / trend graph for product lot release and trend data analysis.
- Review routine data and logbooks.
- General lab support including housekeeping, equipment maintenance, document archival, maintaining logbooks and inventory of lab supplies, etc.
- Problem solving of testing related issues as well as troubleshooting of equipment.
- Author and/or update existing SOPs, Forms, OJTs and TMs as needed.
- Initiate discrepancy record, perform discrepancy assessment and identify corrective actions where necessary.
- Train other analysts on methods and/or SOP.
- Responsible for ensuring that all training required to support / perform GMP activities are completed timely.
- Participate in internal / external audits and regulatory inspections.
- Raise work notification, g2g shopping cart for
purchase of consumables / reagent / media for Lab use. Follow up on the planned
receipt, Delivery orders, invoices when required.
- Understanding of basic microbiological
principles (bioburden, LAL, plating and counting techniques, etc) and execution
of intermediate techniques (DET, AET).
- Participate in
project, validation and process improvement works.
- Perform equipment qualification / maintenance,
liaise with external / contract lab / vendor.
- Contribute to the continuous improvement of
laboratory procedures and processes to ensure compliance to GMPs.
- Provide forecast for consumables / reagent /
media used and facilitate in budgeting and financial planning.
- Perform sample receipt and storage of QC
samples.
- Manage the life-cycle process for retain and
reserve/reference samples.
- Manage and prepare the shipment of samples to
Receiving labs.
Leadership
- Work co-operatively with the Head of Micro/EM and QC Supervisor to create an environment of strong team spirit, timely and effective communications. Strive towards team’s objectives/goals, takes the initiative and proactively turn ideas into action – to make things happen.
- Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements.
- Embody PT behaviors, lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.
- A team player and the willingness to cover other colleagues in continued support of the Micro/EM operations.
Safety, Health & Environment
- Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
- Observe all RSTO’s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.
Lean Production System
- Embody
PT Lean Production System (LPS), while demonstrating a continuous improvement
mindset and behaviors through the use and application of LPS tools for
continuous improvement initiatives.
Requirements
- Degree
in Microbiology, Biology, Biochemistry or any Life
Sciences discipline or equivalent
- 1-3
years of related working experience for degree holders or
equivalent holders with combination of education and
relative work experience
- Related
working experience in a biotech or pharmaceutical
operating environment is a plus
Knowledge / Skills / Competencies:
- Knowledge
of cGMP relevant to the pharmaceutical industry
- Knowledge
of laboratory safety procedures
- Able
to determine when to escalate issue
- Ability
to organize and plan effectively
- Good
team player
- Demonstrate
excellent verbal and written communication skills in English
Skills Required
- Degree in Microbiology, Biology, Biochemistry, or another Life Sciences discipline, or equivalent
- 1-3 years of related work experience for degree holders, or equivalent education and work experience
- Experience in a biotech or pharmaceutical operating environment
- Knowledge of cGMP relevant to the pharmaceutical industry
- Knowledge of laboratory safety procedures
- Ability to determine when to escalate issues
- Ability to organize and plan effectively
- Good team-player skills
- Excellent verbal and written communication skills in English
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The Company
What We Do
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support. To date, PSC Biotech Corporation now serves 1000 clients in more than 35 countries worldwide through professional services consulting, cloud-based software solutions, pharmaceuticals contract manufacturing, life science investment consulting, and metrology services. PSC Biotech Corporation has six unique divisions within the parent company – each representing one of our areas of expertise: PSC Biotech, PSC Software, BioTechnique™, PSC Partners, PSC Metrology and PSC Investments. Additionally, PSC Asia and PSC Biotech Ltd represent PSC Biotech Corporation in Asia and Europe, respectively. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.
