Quality Administration Specialist

Job Description

Organon is recruiting for a Quality Administration Specialist to join our world class manufacturing site in Cramlington, Northumberland. In this role, you will provide technical administrative support to the Production / Quality department in a number of key areas.

Role Responsibilities:

• Generate, store, distribute and archive Certificates of Analysis (CoA), and related documentation to meet shipping / customer deadlines and to ensure accuracy and completeness.
• Facilitate and maintain customer certification package electronic interface.
• Primary contact to monitor and respond to the CoA email inbox for adhoc requests fielding and escalating general enquiries.
• Perform GMP review of Cramlington batch certificate / release package documentation and associated data as required.
• Administrative functions to support Bulk IPT quality e.g. metric collation, scanning, filing and tracking of customer certification documentation queries and follow up of actions.
• Organisation and maintenance of documentation storage areas.
• Author, review and approval of SOPs / Job Instructions as required.
• Drive and contribute to department continuous improvement using lean principles and identify potential changes.

Skills, Qualifications & Experiences:

• Excellent communication skills and ability to work in cross-functional teams.
• Experience working in a pharmaceutical environment.
• Attention to detail and well-organised approach to working.
• Strong Continuous Improvement mindset with experience and skills in the tools.
• Competent end user of desktop applications e.g. word, pdf, excel and access.
• Support and sometimes lead projects within the team.

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