Proclinical is seeking a dedicated Senior Quality Control Specialist. This role is pivotal in reviewing test methods and raw data for lot release and requires a solid understanding of Quality Control.
The ideal candidate will have practical knowledge of GMPs and regulatory requirements in the product development life cycle, including lot release, stability testing, method qualification and validation, technology transfers, and QC procedures.
Experience in a GMP-regulated environment is essential.
Responsibilities :
- Support Technology Transfer related to new validated assays or process improvements to internal and external laboratory facilities.
- Support Stability Program, data review, protocol and report writing.
- Translate validation reports into technical test methods and SOPs.
- Observe and provide feedback of Quality Control technical operations.
- Analyse and interpret technical laboratory data.
- Support GMP investigations for out of specification test results and corrective actions.
- Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environment.
- Be willing to work flexible hours, including weekends, evenings, and holidays as needed.
Key Skills and Requirements :
- Bachelor's degree in a relevant discipline (biological sciences or equivalent).
- Experience in the biopharmaceutical industry within a Quality Control role.
- Hands-on experience with Cell base Assays, cell culture (primary cells and cell lines).
- Proficient in performing technical writing (e.g., test methods, SOPs, protocols, etc.).
- Detail-oriented with strong analytical, written, and verbal communication skills.
- Ability to effectively manage multiple priorities involving aggressive timelines.
- Flexible and adaptable style with an eagerness to take on challenges.
- Problem solver who not only identifies issues but leads efforts to resolve them.
Interested or know someone who might be? Reach out to Mik Raletz using the following :
1 267 428 7770
Apply Now :
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV.
Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe.
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