Senior QC Micro Analyst

3 days ago

philadelphia, United States Proclinical Staffing Full time

Senior QC Micro Analyst - Permanent - Philadelphia, PA

Proclinical is seeking a Senior QC Micro Analyst to support quality control microbiology and environmental monitoring technical support testing.

Primary Responsibilities:

This role involves performing microbial assays, including bioburden, endotoxins, mycoplasma, gram stain, environmental monitoring, and sterility techniques. The position requires flexibility to work across different shifts, including weekends and holidays, to complete assigned tasks.

Skills & Requirements:

  • Bachelor's degree in Biology, Biochemistry, Microbiology, Chemistry, or a related scientific field, or equivalent combination of education and experience.
  • 3 years of experience in GMP within the pharmaceutical industry in a Quality Control role.
  • Hands-on experience with two or more of the following: endotoxin, mycoplasma, bioburden, sterility.
  • Experience in technical writing (e.g., technical reports, test methods, SOPs, protocols, deviations, CAPAs, change controls).
  • Ability to manage multiple priorities with aggressive timelines at a high level of productivity.
  • Strong technical skills and attention to detail.
  • High level of ownership and accountability.
  • Proficient with Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).

The Senior QC Micro Analyst's responsibilities will be:

  • Work alongside development teams to conduct assay co-qualification, validation, and technical transfer of updated and new assays.
  • Act as a subject matter expert and train new laboratory personnel on assays.
  • Perform GMP Quality Control laboratory testing activities with minimal errors, ensuring compliance with procedures, standards, and GMP regulations.
  • Support thorough GMP investigations for quality events.
  • Author, review, and approve technical assay documents, including protocols, reports, and procedures.
  • Assist in technical problem-solving for GMP Quality Control issues.
  • Generate, revise, and review documentation such as SOPs, protocols, and reports.
  • Initiate and support quality documents such as deviations, laboratory investigations, CAPAs, and change controls.
  • Perform technical review of laboratory data and logbooks.
  • Operate efficiently, producing high-quality and accurate results.
  • Support Health Authority inspections.
  • Provide input to functional laboratory team meetings.
  • Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at m.raletz@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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