Senior Microbiology Associate

2 days ago

Alexandria, New South Wales, Australia Parnell Manufacturing Pty Ltd Full time $80,000 - $120,000 per year

SALARY PACKAGE


•1 x Full Time Position

•Base Salary + Bonus + Superannuation

•Free Car Park for all staff on site

•Office perks including office massage & stocked lunchroom

•Strong company culture

ABOUT PARNELL

Parnell Veterinary Pharmaceuticals is a global animal health company based in Alexandria, Sydney with a focus on innovation and rapid growth. Our unique digital technologies integrate with our innovative products to provide veterinarians, producers and pet parents with unique solutions for their animal health needs. We offer personal and professional development opportunities for those who demonstrate the company's core values of Professionalism, Excellence, and Teamwork, Safety and Sterility and an exciting, fast-paced and entrepreneurial work environment.

THE POSITION

We are seeking a Senior Microbiology Associate to join our team. This role involves ensuring compliance with cGMP regulations across relevant jurisdictions and supporting the Sterility Assurance Program. The responsibilities include managing environmental monitoring, conducting bacterial endotoxin testing, and performing investigations on microbiological deviations or trends. The Senior Microbiology Associate will be responsible for bioburden and endotoxin test methods, as well as overseeing microbiological equipment installation, qualification, and maintenance. The role also includes supporting the development and Continuous Improvement of Quality Management Systems and assisting with internal audits. Additional duties include laboratory housekeeping, test method validation, and reviewing documentation, with other tasks assigned by the Microbiology and Sterility Assurance Manager or VP of Quality. This position reports to the Microbiology and Sterility Assurance Manager.

ABOUT YOU

We will consider candidates that demonstrate the following:

•A team player who enables a culture of execution

•An individual who is both focused on success and has ability to work independently and own their role

•Advanced written and verbal communication skills and a strong aptitude to prioritise your work

•Strong adherence to Continuous Improvement and solutions-based thinking

•Excellent organizational skills and the ability to juggle multiple tasks

•Flexibility with scheduling to meet the demands of an evolving workload

•A proactive attitude and a willingness to take initiative

WORK EXPERIENCE & SKILLS


•Contribute to the development and maintenance of cGMP compliance in production applicable to all relevant regulatory jurisdictions

•Contribute and assist, when required, in the Parnell Sterility Assurance Program and activities that support sterility assurance including but not limited to filtration, gowning, aseptic technique, sterilization, dehydrogenation, media fills, seal integrity, cleaning practices and materials, water systems and sterility testing.

•Performing all aspects of the Environmental Monitoring program which includes but is not limited to, sample selection, sample placement, adding/removing samples, Viable and non-viable (NVP) testing, reading plates, reporting, trending, and reviewing of data according to cGMP and company standard operating procedures.

•Conduct bacterial endotoxin testing for clean steam and WFI according to cGMP and company standard operating procedures.

•Undertake microbiological out-of-specification and out-of-trend (MOOL/MOOT) investigations, document updates, deviation reporting, corrective and preventative (CAPA) investigations, and trend data analysis (on a quarterly basis and where required).

•In process, finished product and raw material Bioburden Test method Validation

•In process, finished product and raw material Endotoxin Test Method Validation

•Undertake the installation and qualification of microbiological equipment

•Conduct internal audits, as required

•Assist with the strategic development, implementation and continuous improvement of existing and new best-practice Quality Management Systems particularly for Quality-Microbiology and Sterility Assurance

•Contributes to the daily operations of the Micro Laboratory housekeeping

•Provide support for the test method validation program

•Responsible for equipment in the Micro Laboratory Calibration and Maintenance Program

•Review of analyses, EM test records and logbooks where required

•Any other tasks related to the role requested by the Microbiology and Sterility Assurance Manager or VP of Quality

ESSENTIAL SKILLS


•B.S. degree in Microbiology or similar discipline

•3-5 years pharmaceutical experience

•Experience in a sterile manufacturer would be highly regarded

Parnell Manufacturing is an equal opportunity employer committed to fostering a diverse and inclusive workplace. We value the unique perspectives and experiences each individual brings to our team and encourage candidates from all backgrounds to apply.

Only successful candidates will be contacted for interview.

Thank you for your interest in joining our team

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