Job Description

The Quality Assurance Manager will be responsible for working closely with the Director, Quality Assurance & Compliance to insure the Biologos facility is meeting all quality requirements, is proactive in determining areas for greater process documentation and always focused on continuous improvement. This position includes a 15+% annual bonus opportunity and a signing bonus, depending on experience and qualifications.

QUALIFICATIONS:

·        Bachelor’s degree in a technical area (Chemistry, Microbiology, Biology, Engineering, or equivalent).

·        Minimum 3-5 years quality system and/or laboratory experience.

·        Minimum 3-5 years of experience within an ISO -certified, GMP environment, preferably ISO 13485.

·        Proficient in Microsoft Office applications – Word, Excel, PowerPoint, Outlook.

·        Knowledge of basic chemistry and microbiological principles.

·        Previous experience in reagent or cell culture media manufacturing a plus. Experience in powders or chemicals processing environment a must.

·        Previous knowledge of cleanrooms, aseptic processing a plus.

·        Strong knowledge of quality system requirements – CAPAs, NCRs, Customer Complaints.

·        Experience in 5S or lean manufacturing environments.

·        Knowledge of process and equipment validation is preferred.

·        Broad experience developing, writing, and auditing Standard Operating Procedures in an ISO environment.

·        Experience in vendor management or vendor auditing.

·        Experience managing controlled documents and working within a QMS.

·        Strong interpersonal & communication skills.

·        Strong analytical and problem-solving skills with experience in disciplined problem-solving methods.

·        Experience with SPC or statistical process analysis.

·        High attention to detail.

RESPONSIBILITIES:

The Quality Engineer is responsible for the following:

·        Work fully within the Biologos Quality Management System.

·        Lead Quality System audits, internal and external.

·        Document production, logistics, sales processes within existing and new SOPs.

·        Write, revise, review controlled documents as required.

·        Ensure compliance with Biologos’ Quality System and Good Manufacturing Practices.

·        Provide support to the Director, Quality & Compliance as required and fully collaborate with the Sr. Quality Assurance Technician. Ensure timely response to internal and external customers’ requests for procedures, studies, data, etc.

·        Develop and maintain trending data for processes to identify areas for improvement or areas that are out of control.

·        Review batch, sales, shipping record documentation for accuracy and completeness.

·        Inspecting critical finished product according to established standards prior to shipment.

·        Performing process validation, cleaning validation, etc., as required.

·        Lead or support Non-Conformance investigations and work with team members to implement associated CAPAs.

·        Work closely with Process Engineer to drive continuous improvement through KPIs and data-driven analysis, while ensuring it is fully validated and documented.

·        Other responsibilities as needed.

Company Description

Biologos has been serving the biologics industry since 1976, producing high quality sterile chemical reagents, cell culture media and serums used in human tissue processing (tissue banks) and animal vaccine development and manufacture. Included among our clients are the top five animal health companies in the world and many of the largest tissue banks in America. Our facility is ISO-13485 and cGMP certified and includes a Class 7 clean room with Class 5 filling capabilities. Biologos was acquired by a private equity firm, Evolve Capital, in late 2015 and has more than doubled in size since the acquisition. We are a small company focused on a growth strategy, organically and through acquisition. Our operations occupy four buildings in Montgomery, IL and will be relocating to a new site north of I88 and west of I355 in Glendale Heights within the next 9 months. If you are passionate about growth, continuous improvement, enjoy teamwork and want to be part of a company that makes a real impact then join the Biologos family and help us meet the critical health needs of people and animals!