QC Specialist, Microbiology

Corden Pharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people’s lives.

Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms:
Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well‑being.

We strive for excellence. We share our passion. Together, we make a difference in patients' lives.

Is responsible for administering the GMP Environmental Monitoring Program for the site for classified spaces for production, packaging, sampling, dispensing, and testing. This person will serve as a Subject Matter Expert for one or multiple microbiological programs.

• Coordinates with safety personnel regarding industrial hygiene requirements and how they reflect into GMP requirements.
• Provides comments on user, functional, and design specifications for classified areas in conjunction with the cross‑functional QA team regarding recommended equipment, accessories, techniques and practices in clean room areas.
• Establishing, revising, and maintaining the GMP Environmental Monitoring Program for the site in accord with recognized standards and regulatory requirements.
• Responsible for the coordination, scheduling, execution, and review of work for on‑going certification requirements to meet technical standards (ISO 14644 or other).
• Responsible for ensuring environments and the supporting utilities (gas and water) are tested and compared to action and alert limits.
• Takes action to investigate and remediate areas to standard.
• Reviews operational procedures and ensures controls and practices are implemented to preserve the environment.
• Monitors activities and provides feedback to Operations and Production personnel on the activities that can cause non‑conformance to specifications.
• Advises on personal protective equipment, surfaces, and equipment required to maintain viable and non‑viable particulate to meet classified requirements.
• Reviews, participates, and authors risk assessments regarding environmental monitoring topics for operational areas in comparison to regulatory requirements, including customer inquiries.
• Able to work under minimal direction and possess the ability to work on complex problems by analyzing procedures and data to create appropriate solutions.

• Isolates and makes cultures of significant bacteria or other micro‑organisms in prescribed or standard inhibitory media, controlling factors such as moisture, aeration, temperature, and nutrition.
• Identifies micro‑organisms by microscopic examination of physiological, morphological, and cultural characteristics.
• Performs endotoxin analysis using turbidimetric and gel clot methods on water and product samples.
• Maintains Micro Lab including supply ordering, sterilization, instrument maintenance, and calibration.
• Generates methods and standard operating procedures relevant to the Micro Lab.
• Participates in required investigations, including review of microbial deviation issues or risk assessments.
• Participates in Regulatory Audits.
• Attends and participates in QC Team meetings. Develops team’s skills.
• Site water activities including coordination of samples with external labs.
• Weekly water samples.
• Critical water samples for investigation to be performed on site.
• Investigation of samples.
• API samples for lot release for all products.
• Includes performing testing for TAMC/TYMC within 24 hours of receipt.
• Microbiological Program and Microbiological lab improvements for continuous improvement.
• Establishment and maintenance of 5S/Lean Lab Principles.
• Trains QC Staff on new Microbiological procedures and processes.
• Qualify new media.
• Viable and non‑viable air sampling.
• Ma…