Senior Specialist Analytical Standard
Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.
We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.
At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.
It’s going to be an exciting future—come be a part of it!
Functions as Change owner and/or SME across small/large molecule, packaging and compendial Analytical Standards (AS).
Assists in monitoring international standard setting activities for articles of impact to Organon.
Demonstrates cross functional engagement and teamwork to maintain compliant analytical standards and complete change control in a timely manner.
Performs core functions accurately and with limited guidance/oversight.
Maintains workload and communicates challenges and delays.
Supports teamwork and continuous improvement projects.
Demonstrates working knowledge of operations to support technical decision making.
Responsible for providing functional support for Analytical Standards and Analytical change control activities for new products, in-line products, packaging, outsourcing, divestitures and compendial compliance.
Partners with change control initiator/owner and various stakeholders in Regulatory, Technology, Supply Chain, Operations, and Quality to coordinate assessment and approval of analytical change controls.
Ensures alignment across subject matter experts and stakeholders to implement analytical changes globally.
Operates in a complex business environment with significant regulatory complexity.
Assists in escalating change control issues through the change control process.
Works with our Company's Manufacturing Division network to remove bottlenecks to ensure on time delivery of the change.
Coordinates resolution of misaligned change control priorities across operating units.
Conduct routine surveillance and tracking of new information and revisions published in the global pharmacopoeias with a focus on articles impacting Organon.
Communicates with impacted stakeholders in a timely manner.
Ensures that all Analytical Standard documents are written clearly and unambiguous, are maintained in accordance with established divisional and departmental procedures and issued in a timely fashion and maintains active ingredient, intermediate, raw material, excipient, component and final product Analytical Standards.
Performs appropriate document review and change control quality approval activities associated with their position and ensures change control is in compliance with all regulatory and current Good Manufacturing Practices (cGMP) expectations.
Maintains a broad based knowledge of cGMP's, our Company's Policies, Procedures and Guidelines, regulatory requirements, compendial requirements, etc. pertinent to the manufacturing, personal safety, control, testing and documentation of pharmaceutical products.
Minimum Education Requirements:
BS degree required, concentrations in life sciences, engineering or related relevant discipline.
Required Experience and Skills:
Minimum of 5 years applied professional work experience in one or more of the following areas: Change Control, Laboratory Operations and/or Quality operations with laboratory oversight.
Working knowledge of analytical techniques used in commercial testing of excipients, drug substance and drug products required, preferably with different product modalities (e.g., biologics and pharmaceutical products).
Ability to lead/work well in teams, managing multiple projects/tasks simultaneously with competing priorities.
Strong collaborative and communication skills.
Please submit you resume in English Language
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.
Subject to applicable law, all prospective US Organon hires will be required to demonstrate that they have been fully vaccinated against COVID-19 with a vaccine authorized or approved by the Food and Drug Administration (FDA), or qualify for a medical or religious accommodation to this vaccination requirement, as a precondition of employment.
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Flexible Work Arrangements:Remote Work
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