QC Microbiology Scientist

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Perform microbiology testing in the laboratory as specified by current procedures.

• Write specifications, sampling instructions, test methods, procedures and other QC procedures.

• Monitor any contract testing laboratory for compliance and test results.

• Ensure laboratory records are evaluated and signed by an authorized person before they are sent to the QA department.

• Ensure accountability, transparency, and effective communication cross-functionally and within the team while guaranteeing information is timely, clear and accurate.

• Coach other team members as required by QC or QA management.

• Ensure team compliance with all policies, procedures and site/company regulations.

• Exhibit accountability and responsibility for an area or process to affect change and lead efforts and ideas to completion.

• 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.

• Verify, review and make appropriate changes if needed, to any controlled document pertinent to area of responsibility.

• Supply the highest level of customer service while having the ability to challenge established procedures and systems.

• Participate in and possibly lead continuous improvement activities.

• 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.

• Report laboratory incidents in a timely manner per site procedures and assist in any investigation processes.

• Verify, review and make appropriate changes if needed, to any controlled document pertinent to area of responsibility.

• Identify opportunities to reduce risk, reduce cost of poor quality and improve service.

QUALIFICATIONS AND REQUIREMENTS:

• Bachelor's Degree in scientific discipline required or equivalent work experience.

• 3 or more years microbiology experience.

• Strong knowledge of cGMP requirements.

• 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 expertise in the manufacture and control of finished products, analytical analysis techniques and statistical quality control.

• Preferred to have working knowledge of regulatory (FDA, EU, ISO, USP, etc) requirements and applicable testing guidelines.

• Preferred ability to use relevant software packages to process and analyze data.

• Preferred experience in equipment/instrument validation/qualification, change control, and investigations.

What We Offer:

• Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.
• Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.
• Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.

Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.