Analyst Quality Operations Analytical Lab – KTL/DPI

Analyst Quality Operations Analytical Lab – KTL/ DPI

As an Analyst you will work in a four-week shift system. This will be early-day-late-day. There will be no work in night shifts and during the weekends.

Purpose of the Role

As an Analyst Quality Operations Analytical Lab – KTL/ DPI you will support the organisation in meeting excellent quality performance by executing various tests on materials or products in order to report on the results. You will partially plan, organise, execute and evaluate the indicated tests under general supervision.

Main Responsibilities

Tests

• Execute and evaluate analytical tests on finished products according to pharmacopoeia and company procedures and standards. Perform all tests based on Heist testing methods and in accordance with SOPs;
• Write the analyses reports;
• Enter the results of the tests clearly, completely and correctly into the LIMS system;
• Initiate deviation reports, initiate « Out Of Trend » or « Out Of Spec » investigation as needed and report the findings;
• Review test results of colleagues (Analysts);
• Results that are not within specifications must be reported to the Senior Analyst/ Supervisor immediately.

Procedures

• Perform all lab activities according to cGMP guidelines;
• Read and handle pharmacopoeia and standards;
• Write and update SOP’s.

Lab equipment and material

• Perform calibrations of balances and glassware and other small instruments;
• Daily review of the temperature and humidity registrations of equipment;
• Follow-up of the stock of all lab material needed;
• Assure that expired materials are destroyed and inventory list is updated.

Miscellanea

• Execute various tasks assigned by supervision (e.g. special request testing, stability testing, identification of finished products, in-process testing, …);
• Responsible for peer-to-peer training;
• Responsible for the cleanliness in the lab according to the housekeeping program;
• Follow-up training database.

Your Profile

• Bachelor’s degree in Science;
• Preferably at least two years of experience in a similar lab position, a graduate is also welcome to apply;
• Knowledge of analytical techniques;
• Knowledge of general software applications (Word, Excel, Outlook. );
• Able to work independently and plan own work;
• Strong team spirit, sense of responsibility and integrity & trust;
• Strong problem-solving skills and accuracy;
• Action oriented and able to deal with ambiguity;
• Perseverant, strong time management and priority setting skills;
• Good oral and written communication skills in English and Dutch.

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

Search Firm Representatives Please Read Carefully
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R514966