Full‑service design firm integrating architecture, engineering, landscape and planning into cohesive built environments.
Write specifications, sampling instructions, test methods, procedures and other QC procedures.
Ensure proper maintenance and cleanliness of the department, premises and equipment.
Maintain an acceptable level of 5S in the area. Assure the laboratories are maintained to promote an organized workspace.
Identify opportunities to reduce risk, reduce cost of poor quality and improve service.
Lead and/or support all investigations. Review and approve area quality and safety exceptions and investigation reports. Ensure on-time completion of investigations and corrective action items assigned to area.
Ensure accountability, transparency, and effective communication cross-functionally and within the team while guaranteeing information is timely, clear and accurate.
Ensure team compliance with all policies, procedures and site/company regulations.
Report laboratory incidents in a timely manner per site procedures and assist in any investigation processes.
Perform microbiology testing in the laboratory as specified by current procedures.
Coach other team members as required by QC or QA management.
Verify, review and make appropriate changes if needed, to any controlled document pertinent to area of responsibility.
Participate in and possibly lead continuous improvement activities.
Ensure laboratory records are evaluated and signed by an authorized person before they are sent to the QA department.
Monitor any contract testing laboratory for compliance and test results.
Preferred experience in equipment/instrument validation/qualification, change control, and investigations.
3 or more years microbiology experience.
Preferred expertise in the manufacture and control of finished products, analytical analysis techniques and statistical quality control.
Complete understanding and application of principles, concepts, practices, and standards for testing performed in all QC laboratories through hands-on experience working in a Pharmaceutical manufacturing facility laboratory.
Preferred ability to use relevant software packages to process and analyze data.
Supply the highest level of customer service while having the ability to challenge established procedures and systems.
Exhibit accountability and responsibility for an area or process to affect change and lead efforts and ideas to completion.
Strong knowledge of cGMP requirements.
We at ELIQUENT are looking for an experienced QC Microbiology Scientist to immediately join our ELIQUENT Engineering - Chicago team. The QC Microbiology Scientist manages the activities of a dosage pharmaceutical quality control unit in the performance and analysis under GMP conditions for the entire site. Scope of responsibility includes raw material, in-process and finished goods testing and release as well as stability requirements for finished packaged goods. It also includes Environmental Monitoring of controlled environments to assure controlled environments are maintained.
Preferred to have working knowledge of regulatory (FDA, EU, ISO, USP, etc) requirements and applicable testing guidelines.
Bachelor's Degree in scientific discipline required or equivalent work experience.