Work Schedule
Standard (Mon-Fri) Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description Position Summary:Manufacturing of biopharmaceutical products is required to be in compliance with international quality requirements as defined by TGA, FDA, EMA and other regulatory agencies as applicable.
To achieve compliance, quality systems are defined, implemented and maintained.
The Quality Control Laboratory is responsible for the execution of Qualification/Validation Protocols, Technical Transfer (as applicable) and Performance for Quality Control tests undertaken within the Quality Control Laboratory.
Key Responsibilities:Perform QC microbiological testing and associated tasks, including bioburden testing of process intermediates, crude harvest, drug substance, and WFI.Perform environmental monitoring including surface monitoring, active and passive air sampling.Participate in activities related to analytical method verification and QC test strategy to meet or support the client's requirements and/or expectations.Perform growth promotion testing of microbiological media used in testing.Responsible for stock control within the Microbiology laboratory.Perform all work in a safe manner adhering to EH&S safe working practices, including wearing of personal protective equipment (PPE).
Conduct proactive hazard identification and report any accidents, incidents and near misses.Actively contribute to process improvement initiatives.
Prepare, maintain and improve the quality of microbiological generated documents including SOPs, Specifications, Test Methods, Policies, Summary Reports and Investigation Reports.
Initiate and implements Change Controls.Actively contribute to raising Change Controls, report and investigate microbiological excursions (OOS, DRs).Provide microbiological technical support and input into Quality related issues.
Communicate effectively across departments and internal customers.Perform internal and external networking with other microbiologists and external specialists for benchmarking and development.Maintain accurate documentation in adherence to GMP standards.
Conduct studies following the latest guidelines.Perform training of QC Microbiology staff and other staff as required.Contribute to regulatory and client audits when required.Frequent Contacts: All internal Departmental staff including QC Senior Manager, QC Microbiology Supervisor, QC Staff, Operations and Engineering.
How will you get here?
Motivated and self-directed individualPositive work ethic and can- do attitudeComputer literate in word processing, spreadsheets, databasesAn excellent communicator coupled with good report writing skillsOrganised with a proven ability to prioritise tasks according to customer requirements Education:Tertiary Science qualification (either degree in a related science field or post-secondary education in an appropriate field) with experience in laboratory testing, good aseptic technique and validation required for the bio-pharmaceutical industry. Experience:Experience of working in a manufacturing or laboratory environment with knowledge of bio-pharmaceutical processes and pharmaceutical guidelines preferred.Background in Microbiology and/or related field.
Familiarity with principles of maintaining a sterile environment and conducting microbiological tests is preferred.Knowledge of GLP, cGMP, and Quality Principles.Proven record of ability to work as a team member and independently as required.Ability to effectively manage multiple tasks, prioritize responsibilities, and take proactive measures to accomplish assigned duties in line with company objectives.A track record showing good oral and written communication skills.Computer literate in word processing, spreadsheets and databases.What will put you ahead of the competition?
Being meticulous and having a high attention to detail.Strong multitasking and prioritisation skills.Having a disciplined, methodical and systematic approach to work.Proven team participation skills.What's in it for you?
Work in a highly motivated and customer focussed team.Access to a strong culture of process improvement initiatives.Access to global training via Thermo Fisher's global University.Exposure to market leading cutting- edge technologies.A competitive salary and performance related bonus structure.Development opportunities as part of a rapidly growing global organisation. Other Job Requirements:Adhere to OHS policies and procedures and ensure a safe and healthy workplace environmentAdhere to the Chain of Responsibility obligations under the Australian Heavy Vehicle National LawYour position may require you to participate in on call work.
If you are on call you are required to be available for immediate return to work outside of your normal and regular work pattern.
Should this be a requirement of your position, you will be remunerated per the Company's policy.
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