Assoc. Spclst, Quality Control

The position of Associate Specialist in In-Process Control Lab will be responsible for ensuring and maintaining high standards of quality and compliance within our organization.

In this role, you are required to perform shift work (12 hours rotating shift (day/night) including Sat/Sun and will be responsible for all or subset of the key responsibilities below:

Responsibilities

• Performs analytical testing and review/ release, of in-process samples, cleaning samples, utility systems, intermediates and finished drug substances according to approved procedures.

• Ensures tests assigned are performed in a timely manner in compliance to test methods and standard operating procedures with necessary laboratory safety precautions

• Participates in analytical method transfer, validation, verification, new product introduction, and equipment qualification.

• Assists in conducting laboratory investigations and ensure effective implementation of related actions within the agreed timeframe.

• Participates in Laboratory safety and/or compliance walkthroughs and respond to regulatory, compliance, and audit related matters, where applicable.

• Provides input for the development and revision of Analytical Standards, Standard Operating Procedures, Work Instructions, and other GMP documents.

• Maintain proper laboratory housekeeping, laboratory inventory, and ensure inspection readiness.

• Execute quality and laboratory improvement initiatives and other projects within the organization.

• Performs equipment preventive maintenance and calibration.

• Performs review of laboratory documents such as orphan data check and equipment logs.

• Performs other duties as assigned by the direct manager.

Qualifications

Required

• Bachelor's degree in Science/Life Science, Pharmaceutical Science, Engineering, or proven relevant experience.

• 2 to 3 years of applied professional work experience in the quality laboratory.

Preferred

• Leadership skills and ability to influence and collaborate with stakeholders at various levels.

• Customer focus with strong business acumen and continuous improvement mindset.

• Strategic and critical thinking mindset with a collaborative and problem-solving attitude.

• Strong communication and interpersonal skills.

• Ability to work effectively in a team-based environment.