Associate Specialist, Quality Control

Posted 2 Days Ago
Be an Early Applicant
Hiring Remotely in Molenstraat, Loon op Zand, NLD
Remote
Senior level
Healthtech • Pharmaceutical
The Role
Coordinate and prioritize QC analytical operations, review and approve physical and chemical test results, manage deviations and CAPA, maintain GMP documentation, train staff, ensure 5S and audit readiness, and assume operational leadership in the lab coach's absence.
Summary Generated by Built In

Job Description

Associate Specialist, Quality Control

Welkom in ons team

De Associate Specialist QC-AC rapporteert aan de Lab Coach Product Lab QC-AC en werkt binnen een team van 10-15 FTE’s bij Quality Control Analytical Chemistry (QC-AC). Het team is verantwoordelijk voor het uitvoeren van fysische en chemische testen op eindproducten en stabiliteitsmonsters.

Doel van de functie:

De Assoc. Specialist QC-AC is verantwoordelijk voor de coördinatie en prioritering van operationele activiteiten, met als doel analyses tijdig en binnen de gestelde termijnen uit te voeren en te rapporteren. Daarnaast is hij/zij verantwoordelijk voor het beoordelen en vrijgeven van fysische en chemische analyses van eindproducten, stabiliteitsmonsters en overige productiegerelateerde monsters. Bij afwezigheid van de labcoach neemt de Assoc. Specialist QC-AC diens taken over, met name op het gebied van operationele aansturing.

Verantwoordelijkheden:

  • Waarborgen van de continuïteit van operationele activiteiten bij afwezigheid van de labcoach (leidinggevende);
  • Beoordelen en goedkeuren van analyseresultaten;
  • Evalueren en opvolgen van afwijkingen;
  • Ondersteunen bij het oplossen van problemen en afwijkingen;
  • Initiëren en coördineren van CAPA-trajecten;
  • Opstellen en actualiseren van GMP-documentatie;
  • Opleiden van laboratoriumpersoneel in kwaliteitscontroleprocedures en -protocollen;
  • Bijdragen aan de continue optimalisatie van kwaliteitscontroleprocessen en -procedures;
  • Waarborgen van orde en netheid in de werkruimtes en naleving van 5S-principes;
  • Beantwoorden van vragen tijdens interne en externe audits.

Jouw Profiel:

  • Opleidingsniveau: minimaal een hbo-diploma in Analytische Chemie of een vergelijkbare richting;
  • Minimaal 5 jaar werkervaring binnen een analytisch laboratorium;
  • Grondige theoretische kennis van alle relevante analysemethoden en technieken binnen het takenpakket van het team;
  • Sterke communicatieve en sociale vaardigheden;
  • Zelfstandig, besluitvaardig, kritisch en nauwkeurig;
  • Uitstekende beheersing van zowel de Nederlandse als de Engelse taal;
  • Beschikbaarheid: het betreft een functie van minimaal 32 uur per week (80%).

Wij bieden:

Werken bij ons betekent samen werken aan gezondheid in een internationale werkomgeving met toegewijde collega’s. Je krijgt alle ruimte om jezelf te ontwikkelen en te laten zien wie jij bent. Verder kan je rekenen op aantrekkelijke arbeidsvoorwaarden:

•                 Een competitief salaris;

•                 35,5 vakantiedagen;

•                 8% vakantietoeslag en 3% eindejaarsuitkering;

•                 Incentive Plan;

•                 Een uitstekend pensioen;

•                 Reiskostenvergoeding;

•                 Ouderschapsverlof voor beide ouders;

•                 Verschillende trainingsmodules.

Secondary Job Description

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.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. 

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. 

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Skills Required

  • HBO degree in Analytical Chemistry or similar
  • Minimum 5 years' experience in an analytical laboratory
  • Strong theoretical knowledge of relevant analytical methods and techniques
  • Knowledge and experience with GMP and QC documentation practices
  • Experience initiating and coordinating CAPA and deviation handling
  • Experience supporting internal and external audits
  • Excellent command of Dutch and English
  • Availability for at least 32 hours per week (80%)
  • Strong communication, training, and leadership skills
  • Attention to detail, independent decision-making, and critical thinking

Organon Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Organon and has not been reviewed or approved by Organon.

  • Strong & Reliable Incentives Quarterly bonuses and performance-based long-term incentives are frequently emphasized as meaningful components of total rewards, sometimes contrasted favorably with larger pharmaceutical firms. Recognition programs and an annual incentive process reinforce a pay-for-performance approach.
  • Parental & Family Support Twelve weeks of gender-neutral paid parental leave and twenty days of bereavement leave, including coverage for pregnancy loss, signal a robust family support offering. Caregiving concierge services and flexible leave practices further strengthen support for caregiving needs.
  • Retirement Support Retirement plans include employer contributions across many markets, with U.S. materials highlighting matching and additional company retirement contributions. This structure is presented as a core part of the financial benefits package.

Organon Insights

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The Company
HQ: Jersey City, NJ
6,952 Employees

What We Do

Organon is a global healthcare company with a portfolio of therapies and products in women’s health, biosimilars, and established medicines across a wide array of conditions and diseases. Our mission is to deliver impactful medicines and solutions for a healthier every day. This site is intended for residents of the United States and its territories. You are reminded to protect yourself against recruiting fraud from individuals, organizations or other entities claiming to represent Organon. All official Organon recruitment emails will come from accounts formatted as [email protected] or [email protected], and Organon will never conduct interviews by chat or email, or make job offers through social media or online forums. All candidates for roles at Organon will first meet with a recruiter and interview team, via Teams or in person. Organon will never ask you to make financial transactions on its behalf or ask you to receive or ship packages or goods. For more information on adverse event reporting, visit http://bit.ly/AEReporting. To read our community guidelines, visit http://bit.ly/OrganonCommunityGuidelines. Follow us on Twitter at Organon (@OrganonLLC). Follow us on Instagram at Organon (@OrganonLLC).

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