QC Senior Laboratory Technician Chemistry

Prothya Biosolutions; Amsterdam; On-site; EUR 42,000 - 56,000; Full time

Benefits offered by this job

Competitive salary

Budget for holiday allowance and year-end bonus

Personal training budget

Contribution to travel expenses

Pension plan

Job summary

A pharmaceutical company in Amsterdam is seeking a Quality Control Senior Laboratory Technician. This role involves performing a variety of chemical tests to ensure compliance with regulatory standards. Responsibilities include routine testing, documenting results, and collaborating with cross-functional teams on product release. Candidates should have a secondary laboratory education and experience in a GMP-regulated environment. This position offers a competitive salary and benefits including training budgets and travel expense contributions.

Qualifications

• Experience in a pharmaceutical laboratory or GMP-regulated environment preferred.
• Proficient in chemical testing techniques, spectroscopy, and titrations.
• Strong communication skills and ability to work in a regulated environment.
• Proficiency in data analysis and laboratory software (e.g., SAP).
• Attention to detail and ability to work in a regulated environment.
• Strong communication and collaboration across teams.

Responsibilities

• Perform routine chemical testing of raw materials and finished goods.
• Document all testing activities in compliance with GDP and GMP regulations.
• Collaborate with cross-functional teams for product release.
• Calibrate and maintain chemical testing equipment.
• Collaborate with QA, Manufacturing, Product Support and Regulatory Affairs.
• Assist in development and validation of testing methods.
• Adhere to GxP requirements and maintain training records.
• Assist in investigations of deviations and CAPA procedures.

Skills

Chemical testing techniques

Data analysis and interpretation

Collaboration

Attention to detail

Problem-solving skills

Education

Secondary laboratory education (K)MLO or related

Tools

Laboratory software applications (e.g., SAP)

Laboratory instrumentation

Job description

Overview

The Quality Control (QC) Senior Laboratory Technician - Chemistry plays a critical role in ensuring compliance of our pharmaceutical products and raw materials. As a QC Laboratory Senior Technician you are responsible for performing a variety of chemical tests and analyses in accordance with regulatory requirements, Good Manufacturing Practice (GMP) guidelines, and internal quality standards.

Responsibilities

• Perform routine chemical testing of raw materials, in-process samples and finished products samples using approved test methods and protocols.
• Document all chemical testing activities, including test results, observations, deviations, and corrective actions, in compliance with Good Documentation Practices (GDP) and GMP regulations.
• Interpret chemical data and results, promptly reporting any deviations or out-of-specification (OOS) findings to management, and assist in investigations and root cause analyses as needed.
• Participate in the qualification, calibration, and maintenance of chemical testing equipment and instrumentation, ensuring accuracy, reliability, and compliance with regulatory standards.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Product Support and Regulatory Affairs, to support product release, investigations, and regulatory submissions.
• Assist in the development, optimization, and validation of chemical testing methods and procedures to ensure robustness, accuracy, and reproducibility.
• Takes GxP requirements into account during preparation, execution and reporting of GxP activities. Is fully aware of key standard operating procedures such as procedures for events, out of specifications and good documentation practice. Follows mandatory GxP training and maintains an appropriate training record. Identifies and escalates GxP issues.
• Assist in the investigation and resolution of laboratory deviations, non-conformances, and customer complaints, following established Corrective and Preventive Action (CAPA) procedures.

Other responsibilities

• Legal compliance
• Stay current on evolving legal requirements related to pharmaceutical manufacturing.
• Ensure the organization's compliance with applicable laws, regulations, and industry standards.
• Environmental health and safety (EHS) compliance
• Adhere to EHS policies and practices within QC.
• Adhere to all safety protocols and regulations in the laboratory environment, including proper handling, disposal, and containment of microbiological hazards and biohazardous waste.
• Supports measures to ensure a safe and environmentally responsible workplace within QC.

Qualifications

• Secondary laboratory education, (K)MLO or related.
• (internship) experience working in a pharmaceutical laboratory/ in a GMP-regulated environment is preferred.
• Knowledge of chemical testing techniques, spectroscopy, titrations and various assays.
• Proficiency in data analysis and interpretation using laboratory software applications (e.g., SAP).
• Excellent attention to detail, organizational skills, and ability to work effectively in a regulated environment.
• Strong communication skills and ability to collaborate with cross-functional teams.
• High level of independence is required when carrying out work according to guidelines, procedures and protocols.
• Perseverance and patience are required during routine analysis and the collection of data for deviations.
• Accurate, structured, flexible, and quality and safety conscious.
• You are able to work under time pressure and you can organize and plan your work independently.
• Hands-on problem solving skills – translating your understanding of the problem into an approach towards a solution.
• Good command of the English language is required, and at least a basic understanding of Dutch.

What We Offer

• A full-time position with a competitive salary.
• A budget of 16.66% (holiday allowance and year-end bonus) of your gross salary, which can be used monthly.
• Personal training budget of €2,100 every 3 years.
• Contribution to travel expenses from the first kilometer.
• Good accessibility by public transport, with private parking options available.
• Pension plan with Zorg & Welzijn.