Quality Control Specialist — Junior
Descrizione dell'offerta
As a Junior Quality Control Specialist, you will be a key member of the Quality & Regulatory Affairs (Q&RA) department, reporting directly to the Quality Control Director (QCD). Your primary mission is to ensure the excellence of our products through the execution and recording of quality control and in-process tests on finished products, intermediates, and research samples. You will be the guardian of product compliance, identifying any deviations and ensuring that every batch meets our rigorous acceptance criteria and regulatory standards (ISO 13485, MDR, FDA).
Key Responsibilities
In accordance with the company’s Quality Management System, your main duties will include:
- Testing & Reporting: Independently perform QC tests and in-process tests on finished products, intermediates, and R&D samples, ensuring all results are accurately recorded in the appropriate logs.
- Deviation Management: Promptly notify management of any deviations from testing plans or delays in scheduled activities.
- Method Validation: Collaborate in the validation of testing methods to ensure reliable and reproducible results.
- Laboratory Management: Assist in the proper management and maintenance of laboratory instrumentation and equipment.
- Non-Conformity & CAPA: Collaborate in the management of non-conformities, corrective/preventive actions (CAPA), and process/product risk management within your area of competence.
- QMS Support: Assist in drafting and updating Quality Management System documentation and managing change controls.
Required Skills & Qualifications
Mandatory Requirements (Must Have)
We are looking for self-motivated individuals who are eager to learn and driven to build a career in Quality Control.
Our team invests heavily in coaching new hires.
- Education: Master’s Degree in scientific or technical disciplines (e.g., Engineering, Biotechnology, Biology, Pharmacy).
- Analytical Knowledge: Basic understanding of analytical methods for the characterization (chemical-structural, mechanical, and morphological) of chemical, raw material and polymeric biomaterials.
- Languages: Good proficiency in English, both written and spoken, for technical reporting and documentation.
- Quality Standards: Familiarity with laboratory best practices (GLP) and a strong interest in medical device regulations (ISO 13485, MDR, FDA).
- Extreme Precision & Reliability: An uncompromising “zero-error” mindset when performing tests and reviewing data.
- Integrity: Absolute commitment to data accuracy, traceability and compliance with established protocols.
- Teamwork: Ability to collaborate effectively within a structured Quality & Regulatory department.
Preferred Requirements (Nice to have)
- Biological Testing: Previous experience or specific academic knowledge of in-vitro cytotoxicity assays for biomaterials.
- Organizational Awareness: Knowledge of the organizational and operational dynamics within a manufacturing company.
- Software Skills: Proficiency in MS Office (Excel for data analysis) and familiarity with Laboratory Information Management Systems (LIMS).
- Autonomy: Ability to manage assigned daily tasks independently once trained.
- Proactivity: A “fast learner” attitude with the ability to adapt to a fast-paced and evolving startup environment.
- Problem Solving: Basic capability in assisting with root cause analysis and the management of non-conformities.
What We Offer
The company offers a structured onboarding program, including a two-month period of induction, training, and close mentoring to support the successful integration of the selected candidate. Depending on the candidate’s profile and assessment, the company offers either an apprenticeship contract or a permanent employment contract, with a starting gross annual salary (RAL) of € 26,000 under the Chemical Industry SME collective agreement (CCNL Chimico Confapi), which will be adjusted based on knowledge and experience. The compensation package also includes:
- annual company’s performance bonus of € 2,300 gross
- a € 1,000 annual welfare allowance
- € 8 meal vouchers for each working day
- hybrid work policy with one day of remote work per week
- accident and supplementary health insurance coverage
In accordance with current regulations, this position is open to candidates of all genders, without any form of discrimination.
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