QC Microbiology Lead

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Job description

QC Microbiology Lead

Our client is dedicated to bringing innovative therapies or unmet medical needs to patients. In doing so each function is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) recognizing the sense of urgency in areas of high medical need.

*Position in the organization*

The Quality Control (QC) department is responsible for monitoring the quality of our AAV-based products, and the quality of the raw materials and starting materials used. QC is also responsible for execution of the Environmental Monitoring (EM) program in place to monitor the manufacturing environment (clean rooms). These activities are all performed in accordance with cGMP guidelines, and are supported by departmental and inter-departmental policies and standard operating procedures.

*Purpose of the role*

The professional will be responsible for routine/non-routine QC sampling and testing according to Standard Operating Procedures (SOPs). The focus is to raise a QC organization.

*Key Responsibilities*

* Participate in equipment validation, method transfer/validation
* Establish, revise, review and maintain procedures (including protocol and technical report).
* Responsible for change control and deviation related to QC operations, including assisting with LIs, OOSs, and OOTs.
* Oversee sampling and storage of QC samples and maintain retain inventory.
* Maintenance of laboratory equipment/instrument and systems to ensure compliance.
* Perform routine/non-routine testing of in-process, final product, raw material samples in accordance with Standard Operating Procedures (HPLC, Protein Assays (Bradford, Lowry), Q-PCR, Potency Assay, Western Blot, Refractometry, Osmolality, ELISA, etc.)
* Water testing (such as heavy metals, nitrates, pH, conductivity, and TOC, etc.).
* Responsible for protocol and report generation/revision, as required.
* Perform sample management such as receipt, inventory, tracking, and aliquoting.
* Coordinate shipment of samples to contract testing laboratories, as required.
* Assist with data trending and aid in compilation of trend reports.
* Complete documentation in accordance with current Good Manufacturing Practices (cGMP).
* Maintain QC lab and related systems to ensure compliance with industry standards.
* Troubleshoot equipment and analytical testing methods.
* Training of other QC Analysts within the department.

*Experience and Skills*

* BS in Chemistry/Biochemistry or other related science.
* Minimum 3 years of analytical laboratory base experience within QC testing capacity, preferably in cGMP environment.
* Well versed in cGMP/ICH/FDA/EU regulations and guidelines.
* Thorough understanding of industry testing requirements/standards.
* Capable of working with minimal supervision.
* Excellent analytical and relevant instrumentation skills such as Q-PCR, Osmometer, Refractometer, HPLC, and Gel Electrophoresis, etc.
* Computer literacy (MS Word, Excel, and LIMS).
* Good/effective communication and organizational skills with the ability to work well with others and independently.
* Ability to manage multiple activities with challenging timelines.