Production Quality Control (PQC) Team Leader

When you are part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $25 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Working as part of our Microbiology Division (MBD), within the Specialty Diagnostics Group, you’ll play an active part in helping us to achieve our mission to enable our customers to make the world healthier, cleaner and safer. The Microbiology Division discovers microbiological solutions for the diagnosis of infectious disease and detection of bacterial contamination. We serve public health, clinical laboratories, food companies, environmental screening and pharmaceutical laboratories with a portfolio of products that include culture media, antimicrobial susceptibility testing solutions and market-leading molecular solutions for food safety testing.

What will you be doing?

As Perth ramps up the MBD response to COVID 19 The Production Quality Controller (PQC) Team Leader will ensure control of quality within production is maintained throughout the production process. This will be achieved through managing the PQC staff and supporting the Lead PQC and ensuring they achieve their daily and weekly objectives. In addition, the PQC Team Leader will monitor the quality compliance in the media prep and aseptic filling areas and report through the Quality Supervisor and other quality personnel on findings. The PQC Team Leader position requires the ability to manage team members on a variety of shifts and report out performance and promptly escalate issues as required.

The role will be working with operations to produce a world class Right First-Time process to provide on time delivery to our customers. Included in the roll will be the monitoring and reporting of KPI’s and participating in cross functional daily tier meetings.

Be the voice of quality within the process by supporting operations with a quality mind-set

Responsibilities 

• The management of a team of PQC staff imbedded within manufacturing.
• Creating Visibility and Driving Actions to provide high quality on time product availability
• Promptly resolve quality issues and escalate as required
• Liaise with Production Leads and Quality Engineers / Quality Supervisor to resolve quality issue promptly
• Communicate with training officers to ensure production staff are trained effectively
• Ensure all Batch Manufacturing Records (BMR) are completed and accurate prior to them passing to QA in accordance with cGMP good documentation requirements
• Ensure batches are sent for QC testing when the batch is complete
• Report unsafe or poor-quality practices immediately through the appropriate channels
• Report KPIs and participation in Daily Tier Board Meetings
• Review any audits of rework and provide quality approval
• Provide training and guidance on good quality practices
• Monitor and coach aseptic practices / Provide aseptic gowning training

Experience, skills & abilities required:

• Experience of people/team management
• HND or higher education level in a Scientific or engineering subject
• A working knowledge of Quality systems ISO 13485 / 9001 / GMP requirements
• Experience of clean room production environments
• A Quality / Customer driven mind-set
• Good communication skills, written and verbal
• Experience of production or laboratory clean room environments

Preferred

• QMS auditor
• Power BI reporting experience
• SAP experience
• Excel competency

How will you get there?

• Consistently demonstrates our 4i Values of Integrity, Intensity, Innovation & Involvement
• Puts the Customer First
• Owns Their Results
• Finds a Better Way Every Day

Days / Shifts: Rotating : Days (Requirement to be flexible with hours / days work)

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.