Job Description
Position Overview
A Quality Assurance (QA) Specialist ensures that products hat every product meets the highest standards of safety, integrity, and regulatory excellence. The role focuses on preventing defects, improving processes, and maintaining consistent product quality through systematic evaluation, monitoring, and documentation.
QA Specialists work closely with cross‑functional teams—including Production, Quality Control, Engineering, and Supply Chain—to identify quality gaps, lead corrective and preventive actions, and drive continuous improvement initiatives.
Responsibilities
Oversee production and GMP activities to ensure compliance with cGMP, QMS, and global regulatory standards.
Conduct end-to-end reviews and release of materials and finished goods, safeguarding product integrity and patient safety.
Drive continuous improvement through Gemba walks and proactive investigations.
Partner with production teams to achieve customer delivery targets, optimize cycle times, and elevate performance metrics.
Support audits, data integrity initiatives, and provide SME input for Quality Risk Assessment and regulatory activities.
Required Education, Experience and Skills
Pharmacy degree with active STRA license; minimum 1 year of relevant experience preferred.
Strong understanding of directives, standards, policies, and guidelines, with the ability to implement QMS, cGMP, and regulatory requirements across multiple markets.
Proficient in English (oral and written) with excellent communication, teamwork, and organizational skills.
Detail-oriented with strong analytical, problem-solving, and time management abilities.
Willingness to learn and grow in areas such as risk management, supplier/customer collaboration, audit readiness, and continuous quality improvement.
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:
Temporary (Fixed Term)Relocation:
No relocationVISA Sponsorship:
NoTravel 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