Director of Quality

What is driving the need to outsource?

Need for expert observation and feedback on cleanroom gowning, aseptic technique, and behavior, as well as QC aseptic technique within a BSC; plus, need for robust laboratory investigation training and support.

What is / are the location / s?

6555 Carnegie Ave, Cleveland, OH 44103

What types of audits are these for example cGMP, cGLP, cGCP, clinical, etc.?

Primarily cGMP (cleanroom operations, aseptic technique) and laboratory investigation practices.

Are these audits focused on Medical Device, Pharma, Biologics, etc. What products / materials will the audit cover?

Pharma / Biologics manufacturing environment.

Is / are the audit / s initial qualification, routine, for cause, etc.?

Observation and training assessments – for performance improvement and compliance.

Type of experience? Ex-Regulator, Industry Expert? Flexible?

Industry expert in cleanroom operations, aseptic technique, and laboratory investigations. Experience providing remediation recommendations. OTC experience not required here.

Degrees or certifications :

Background in microbiology, biology, pharmaceutical sciences, or related field preferred; relevant industry training in aseptic technique and cleanroom protocols.

What will this person be responsible for? Agenda, Audit, Report, etc.

Project 1 :

• On-site observation of personnel gowning and aseptic technique in Manufacturing, QA, and QC.
• Observation of general cleanroom behavior.
• Review of QC personnel technique in BSC.
• Provide remediation recommendations based on observations.

Project 2 :

Additional skills that would be nice to have :

 Strong coaching / training abilities.

 Experience with investigation root cause analysis and bias mitigation.

 Ability to provide both group and individual instruction effectively.

Additional information about the audits? (Onsite, Remote, Mix, working alone, group?)

On-site, in-person engagement for both projects. Approx. 2–3 days on-site for each project, with possible remote follow-up for laboratory investigations. Consultant will work closely with QA and QC teams.