Lachman Consultants is looking for degreed, “hands-on” Microbiologist Per Diem Consultants who have 1) hands-on experience in the laboratory and 2) worked for an aseptic manufacturing Pharma company where they excelled in the following microbiological skills:
Laboratory test data reviews; current international standards and submission specifications for:
Utilities, in-process, finished product and validation; OOS investigations (performance, mentoring and review); Laboratory facilities auditing; Microbiology testing; Development of microbiology laboratory methods; GxP GAP analysis for laboratory processes; Laboratory equipment commissioning and qualification (review for pre/post-execution; includes automation scope); Method validation review; SOPs (development, mentoring); Change Control (evaluation); and Good remediation skills. Consultants must have: a minimum of a Bachelor’s degree in Microbiology and 10 years’ experience; Detailed knowledge of current FDA regulations and expectations; Verifiable Microbiological familiarity and application with respect to generic drugs; Current “hands-on” Microbiological expertise. Candidates should also have strong communication / presentation skills, verbal and written, and the ability to recognize and differentiate the importance of issues and prioritize accordingly.