QC Scientist, Sterility Control - Permanent - Philadelphia, PA
Proclinical is seeking a QC Scientist, Sterility Control. This role is responsible for assisting in the development and implementation of all microbial contamination control processes/procedures for the company's clinical and commercial programs at two manufacturing sites in Philadelphia.
Primary Responsibilities:
This role will effectively collaborate with multiple stakeholders to ensure the harmonized execution of contamination control policies across the two manufacturing sites in Philadelphia. This role will also support new product transfers related to contamination control aspects of manufacturing process and equipment design, microbial method validations and rapid microbial methods.
Skills & Requirements:
- Bachelor's degree in a relevant discipline (biological sciences or equivalent)
- Minimum four to Five (4-5) years of experience in the pharmaceutical industry within a Quality Control Sterility Assurance role or Microbiology role
- Knowledge and familiarity with cGMP/ICH/FDA/EU Annex 1 compliance regulations and USP, EP and JP monographs for microbiology.
- Experience with microbiological concepts and aseptic behaviors, media fills, environmental monitoring.
- Hand on experience running or validating microbiology rapid safety methods (endotoxin, mycoplasma, and sterility).
- Experience with microbiological risk assessments, trending, protocol and report generation.
- Extremely detail-oriented with strong analytical, written, and verbal communication skills.
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
- Flexible and adaptable style with an eagerness to take on challenges.
- Problem solver who not only identifies issues but leads efforts to resolve them.
- Excellent oral and written communication skills with strong technical writing experience required.
- Competent in use of Microsoft Office programs, LIMS, Visio, and/or Jump software
The QC Scientist, Sterility Control's responsibilities will be:
- Assist in developing sterility assurance principles, focusing on aseptic processing and contamination control.
- Support compliance with global microbial control standards, including environmental monitoring and clean-room management.
- Design and update contamination control strategies and risk assessments.
- Conduct gap/risk assessments in response to regulatory updates.
- Develop and oversee the EM testing program for regulatory compliance.
- Lead microbiology-related investigations and participate in new product introduction teams.
- Select and qualify laboratory equipment for microbiological testing.
- Align and harmonize global microbiological standards and practices across sites.
- Participate in facility design, cleaning, and sanitization programs.
- Troubleshoot contamination issues and author trend deviations.
- Initiate change controls and update EM trackers.
- Implement continuous improvement and best practices.
- Perform regular assessments and audits of manufacturing areas.
- Author procedures, protocols, and reports for EM programs.
- Provide oversight for microbiology personnel during safety assay validation.
- Evaluate technical data and perform statistical analysis.
If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at j.cerchio@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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