Specialist, Quality Assurance

The Position:

Ensures that all products supplied by Organon network are received, analyzed, stored, and released in accordance with ORGANON expectations and all applicable country regulatory requirements. Responsibilities include involvement or leadership in activities such as medical device, laboratory quality oversight and Importer’s warehouse quality oversight including regular walkthrough audit, inspection/audit readiness & support, support of product release, local repackaging, deviation investigations, and compliance initiatives.

Responsibilities:

Requires minimal support and oversight from the manager to complete responsibilities. Understands requirements for the role and has knowledge of assigned responsibility areas, including a combination of analytical/scientific skills in order to effectively manage and control activities necessary to comply with Importer’s GMP/GDP regulation and to conduct external partner quality oversight to support ORGANON business.

Ensure compliance with Importer’s GMP/GDP regulation:

• Local quality release for imported product

• Maintain quality system: Deviation/Change Control/Annual Product Review/Auditing/Training/GMP document, etc.

• Importer’s warehouse quality oversight

• Imported Medical Device Quality assurance

External Partner Quality Oversight:

• Contract laboratory quality oversight

• Importer's warehouse management

Support New Product Launch

• Method Transfer liaison

Participate in local/regional Compliance and Quality Initiatives

Note: The roles can be shared with peers and will be adjusted depending on the individual qualification.

Required Education, Experience, and Skills:

• A Bachelor or higher degree in Pharmacy or Chemistry or Biology or Engineering or related one.

• 5 or more years relevant experience in the pharmaceutical industry is preferred. (i.e. QA, QC or Production, QC experience is preferred.)

• Leadership & Skill: Demonstrate strong responsibility and knowledge of applicable cGMP requirements based on sound scientific principles, theories, concepts, and techniques and skills. Strong interpersonal, relationship building and leadership skills; as well as good and effective communication, negotiation, and persuasion skills. Fluent in English, both spoken and written.

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

Requisition ID:R535604