Qc Microbiology Analyst

2 months ago


Mulgrave, Australia Pfizer Full time

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality control team. You will have the role of performing the day-to-day environmental sampling and microbiological testing for products manufactured at the PGS Melbourne site. You will ensure sampling, testing and checking of data will be performed within established time-frames to ensure product release requirements are met.

As a QC Microbiology Analyst, your focus is for safe execution of lab activities and for continuous improvement of lab performance when performing the day-to-day microbiological sampling and testing for products manufactured at the PGS Melbourne site. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It- Perform environmental monitoring tasks for the aseptic environment, other controlled areas, and plant utility systems following specified instructions and techniques from Standard Operating Procedures (SOP), Training Material, and other GMP documents.- Microbiological testing of water, raw materials, in-process, drug product and stability samples.- Plate reading and biological indicator testing.- Ensure all tasks are completed in a GMP compliant and safe manner.- Document all tasks within MODA, LIMS, or standard laboratory paper documentation utilizing GDP principles.- Perform general lab tasks including cleaning and equipment preparation- Maintain training for all required tasks.- Laboratory support activities including consumable control and qualification.- Perform and assist in additional duties as directed by the Supervisor.- Complete documentation associated with microbiological results in a timely manner.- Report and document any non-conformances to the Supervisor.- Preparation of area documentation (e.g. SOP’s, Reports, Protocols).- Ensure training compliance within the assigned work area and QCM.- Adhere to safety systems within the laboratory and on site.- Maintain Laboratory area, equipment, facilities in a clean, orderly and operational state.- Follow role cards and/or standard work plans for key routine tasks and record variations from the target times.- Attend and contribute to Tier 1 Continuous Improvement meeting/process: including ownership of some activities for implementation of process improvements.- Safe execution of lab activities and for continuous improvement of lab performance.

Qualifications

Must-Have
- Bachelor's Degree
- Ability to work a day, afternoon, night and/or weekend shift.
- Ability to aseptically gown for clean room entry, maintain gowning qualification and lift approximately 12kg.
- Proficient in MS Word, Excel and Powerpoint.
- Good working knowledge of common laboratory databases.
- Knowledge of regulatory compliance requirements for Pharmaceutical manufacturing.
- Good analytical thinking and high-level integrity.
- Able to work well either as an individual or as a team member.
- Excellent interpersonal and communication skills.
- Adaptable to fast-paced environment and flexible with changing priorities.

Work Location Assignment: On Premise

At Pfizer we care about our colleagues’ wellbeing and offer a range of great benefits for them, including:
- Paid parental leave- Access to Health & Wellness apps- Career Growth Experiences program- Recognition & rewards program- Paid volunteer days- Life Insurance Benefits- Pfizer Learning Academy access to top content providers- Access to flu vaccines & skin checks- Options to purchase additional leave- Salary packaging & novated lease options

Quality Assurance and Control

LI-PFE



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