Biological Quality Assurance Specialist

4 days ago


Arthur, Illinois, United States Lynkx Staffing LLC Full time
About the Job

Lynkx Staffing LLC is seeking a skilled Biological Quality Assurance Specialist to join our team. As a key member of our staff, you will play a critical role in ensuring the highest standards of quality and safety in our manufacturing processes.

Job Description

The successful candidate will be responsible for coordinating data for batch release, participating in project/client meetings, and authoring/revising environmental monitoring procedures. You will also perform environmental monitoring activities, including non-viable particulate testing, active air viable monitoring, surface viable monitoring, personnel monitoring, and shipping test samples and equipment to contract laboratories for testing.

You will work closely with our team to ensure that all documentation is completed according to written Standard Operating Procedures in accordance with Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP). Your expertise in compliance requirements will be essential in maintaining an inspection-ready state.

We are looking for someone with excellent communication skills, strong technical writing abilities, and experience in quality systems and interpretation of Quality standards for implementation and review. The ideal candidate will have proficiency in computer software such as Microsoft Office, MODA/LIMS, and familiarity with ISO and EU standards.

Required Skills and Qualifications
  • Bachelor's degree in a science or relevant field required or equivalent experience; minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry
  • Proficient with computer software such as Microsoft Office, MODA/LIMS, Microsoft Visio (preferred), Netsuite (preferred), Maximo Asset Management System (preferred)
  • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review
  • Strong written and oral communication skills
  • Technical training experience
Estimated Salary Range

$60,000 - $90,000 per year, depending on experience and qualifications.

Work Environment

This position requires the ability to work in a team-oriented environment and with clients. You must be able to handle the standard/moderate noise of the manufacturing facility and utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.



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