Quality Analyst Finished Goods

Job Description

The Position

Responsible for sampling and testing activities, including the API & excipients raw materials, purified water monitoring, raw materials reanalysis, commercial finished goods, stability studyies, and method verification & validation studies. This role also involves participating in the calibration, maintenance, and qualification of QC equipment, all in accordance with the quality requirements of PT Organon Pharma Indonesia Tbk.

Responsibilities:

• Clean glassware in the chemical lab following procedures.
• Ensure availability and proper storage of reagents, reference standards, and consumables.
• Responsible for storing reagents, reference standards, and all consumable materials used for operations according to the requirements set by procedures, material Certificates of Analysis (COA), or Material Safety Data Sheets (MSDS).
• Conduct chemical testing on various samples using valid methods and report results timely.
• Manage stock and purchase materials as needed.
• Contribute to stretch objectives and change management tasks.
• Responsible for change management (non-compendial), including documentation, study development design, study execution, and study reporting, according to the specified targets and timeline.
• Handle sample acceptance, storage, and disposal.
• Manage waste and comply with safety and quality requirements.
• Responsible for change management (compendial update), including documentation, study development design, study execution, and study reporting, according to the specified targets and timeline.
• Support the Company's Vision and Mission
• Support and conducting company programs & priorities.
• Foster a cooperative work environment and complete assigned training.
• Promote SHE (Safety, Health, and Environment) culture and cGMP compliance.
• Follow Data Integrity principles and implement Quality Risk Management.
• Respond to internal audits and investigate deviations.
• Investigate safety and quality compliance deviations, conduct RCA, determine CAPA, and complete CAPA tasks within the due date as per requirements and procedures.
• Implement the 5S program, ensuring cleanliness, completeness, and tidiness of the work area.
• Comply with procedures, report deviations and errors to the Supervisor for joint investigation, and support continuous improvement by implementing initiatives to simplify and speed up operations.
• Perform Chapter QMS and/or safety if assigned.

Required Education, Experience, and Skills:

• Minimum educational background of a Secondary School Analyst/Academy Analyst, with a minimum of 6 months of experience in a Quality Control Laboratory, or Bachelor's degree of chemistry or pharmacy.
• Business English and Native Indonesian language proficiency
• Receives guidance from senior team members and manager.
• Builds team effectiveness by integrating diverse perspectives.
• Develops knowledge through structured work and training.
• Accumulates knowledge of Organon standards and processes.

• Understands internal quality guidelines and external regulatory standards.
• Applies technical/scientific data to maintain quality standards.
• Willingness to learn and implement processes to increase efficiency (e.g., IPS).
• Collaborates with customers and suppliers to ensure high product quality.
• Supports a harmonized pharmaceutical quality system across the product lifecycle.
• Understands and applies the Quality Management System.
• Performs lab testing in compliance with Organon Quality specifications and regulatory standards.
• Develops and validates lab methods.
• Supports lab systems, maintenance, and troubleshooting.
• Manages specification and test method documentation through Change Control.

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 relocation

VISA Sponsorship:

No

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

No Travel Required

Flexible Work Arrangements:

Not Specified

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1