We are looking for a results-driven, dynamic, and self-motivated Quality Control Supervisor Technician to join our Physicochemical Laboratory.
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Main responsibilities:
As a Quality Control Supervisor Technician, your responsibilities will include:
* Ensure GMP activities in the physicochemical laboratory.
* Evaluate and review the technical documentation corresponding to the Quality Control of the physicochemical laboratory, as well as the analytical results in routine manufacturing, validation and transfer activities.
* Organize and ensure compliance with the weekly program and coordinate human, material and technical resources to ensure its achievement.
* Propose process improvements aimed at improving quality, cost, performance, time and safety of workers and the environment.
* To train and qualify the analysts to carry out the controls correctly.
* Maintain the installations in perfect state of conservation ensuring that they are operated according to the manuals provided by the manufacturer.
* Carry out the drafting and supervision of standard operating procedures (SOP's).
* Carry out the resolution of deviations in the laboratory.
* Coordinate the release of raw materials and the analysis of intermediates, drug substances and drug products.
* Support stability studies agreed with our customers in collaboration with other technicians.
* Provide production quality support in case of incidents that may arise.
* Approve and close CAPAS (corrective and preventive actions) arising from deviations and applicable efficacy verification.
* Check the correct traceability of the materials consumed in the analysis process.
Assesment criteria:
Education:
* University Degree or equivalent in Chemistry;
Biotechnology;
Biology or similar.
* Master's degree related to the area of study.
* PhD in a related area is valued, but not necessary
Languages:
* Fluent in Spanish. Intermediate level of English (B1 level / First Certificate)
At least 4 years of work experience in/with:
* Use of techniques such as HPLC, UV and IR Spectrophotometry, UPLC, Fluorescence, DAD, UV-VIS...
* Experience with recombinant proteins, mAbs, Biosimilar, ADCs (desirable).
* Experience with pharmaceutical regulatory guidelines.
* Use of Agilent equipment with Empower 3 software.
Other requirements:
* Open to work in shifts.
Why 3PBiovian?
* A permanent and stable position in a competitive growing company.
* A competitive time off package with 41 paid days of vacation.
* Flexible compensation plan, allowing all employees to allocate up to 30% of their gross annual salary to daily services exempt from income taxes (childcare, health insurance, academic training etc.)
* Company benefits club, which allows 3P Biovian employees to obtain exclusive prices and discounts on a multitude of products and services (Booking, FNAC, Rituals, El Corte Inglés etc.)
* All new hires who reside outside Navarra are provided with a relocation service and/or assistance.
* ...And so much more!
Why us?
We know it takes people with passion and a shared purpose to manufacture advanced medicines.
We specialize in process development and cGMP manufacturing of biologics and cell therapy products using microbial and mammalian expression systems. We are with you on your biologics journey, growing with you and supporting you with process and analytical development, preclinical and clinical supply, and commercial production. With a focus on biotechnology applications in both human an animal health sectors, we offer customized solutions that meet the specific needs of all our clients
From development to product delivery, we are with you on your biologics journey. We are a leading global CDMO and preferred partner for pharmaceutical and biotech companies. xhfqzwm We have what it takes to help you improve lives.
It's within us.