Quality Associate - Microbiology

Execute and/or Lead Quality Control team activities to ensure the safety and reliability of Shire products are in compliance with quality and regulatory requirements.  Complete robust investigations that determine accurate root causes and effective corrective and preventive actions.  Maintain effective application of operating mechanisms and quality systems.  Execute tasks in support of Contamination Control Program (CCP) initiatives.  Interface routinely with Manufacturing, Quality Assurance, and Quality Systems to support product fulfillment and regulatory requirements.  Apply Lean and Six Sigma principles through participation in activities such as Rapid DMAIC problem solving and Kaizens.

Act as a Lead relative to investigations and problem solving, with focus on remediation and prevention of issues including microbial contamination

  • Conduct biological, chemical and physical analyses on raw materials, initial, in-process, and final products and samples collected from the environmental monitoring programs at Shire manufacturing facility.

  • Write and execute validations and/or protocols for manufacturing processes and laboratory instruments and methods

  • May serve as a mentor to other Quality Laboratory positions. Provide training and work direction for Laboratory technicians as required. Manage workflow and laboratory release functions in specified laboratory areas and on off shifts.

  • Perform review of test data, which includes overall documentation practices. Perform release functions in LIMS or other computerized systems.

  • Use sophisticated laboratory instrumentation and computer systems to collect and record data.

  • Perform advanced laboratory assays requiring precise analytical skills and understanding of scientific principles.

  • Work on special project/protocol testing that involves new methods and instrumentation. Complete all testing, including special project/protocol testing in a timely and appropriate manner.

  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations. Investigate deviations and write exception documents.

  • Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.

  • Perform laboratory and manufacturing audits as required. Audit and update, as required, SOPs.

  • Perform equipment maintenance and calibrations as required. Troubleshoot and resolve instrument problems.

  • Work with minimal Supervision.

Don't Be Fooled

The fraudster will send a check to the victim who has accepted a job. The check can be for multiple reasons such as signing bonus, supplies, etc. The victim will be instructed to deposit the check and use the money for any of these reasons and then instructed to send the remaining funds to the fraudster. The check will bounce and the victim is left responsible.

More Jobs

Quality Control Analyst Microbiology
Social Circle, GA Shire Pharmaceuticals
Quality Lab Associate III
Social Circle, GA Shire Pharmaceuticals
Associate Dentist - DDS / DMD (General Dental ...
Carrollton, GA Aspen Dental
Clinical Quality Coordinator- Athens, Ga (Trav...
Athens, GA Piedmont Healthcare
Associate Dentist - DDS / DMD (General Dental ...
Blue Ridge, GA Aspen Dental