Quality Assurance Specialist III

AMPAC Fine Chemicals • La Porte, TX

6h • Onsite

About The Position

AMPAC Fine Chemicals (AFC), an SK pharmteco company, is a custom manufacturer of active pharmaceutical ingredients (APIs, Drug Substances) and registered intermediates for customers in the pharmaceutical industry. Our integrated facilities located in California and Texas specialize in process development, scale-up, and cGMP compliant production from kilograms to multi-ton quantities. The Quality Assurance Specialist III is responsible for supporting multiple programs or coordinating quality systems. This role ensures adequate QA support for cross-functional IPT meetings and customer teleconferences, working under general direction.

Requirements

• Typically requires 5-8 years of related experience and a bachelor's degree or 3-6 years of related experience and a master's degree or equivalent experience.
• 5 years of related technical experience or equivalent combination of education and experience.
• Ability to act with a sense of urgency, while maintaining accuracy and data integrity.
• Ability to work in a fast-paced, team-oriented environment.
• Strong attention to detail.

Nice To Haves

• Bachelor’s degree preferred in an appropriate science.

Responsibilities

• Communicates the status of QA-related items to the IPT Team, including batch release and investigation status.
• Provides guidance within approved systems and procedures related to GMP production and product release, which may be required outside of typical working hours.
• Takes an active role in planning and executing action items for production support and product release, including document control and production record review.
• Manages the release of products to support subsequent production and customer release within approved systems and procedures.
• Manages change controls in support of production and release activities.
• Reviews and/or conducts investigations for deviations in production and testing (VAR, MNCRs, OOS/OOT investigations, QCRs).
• Ensures process validation and qualification requirements are established in approved protocols and results are adequately presented in approved reports.
• Conducts facility audits of respective manufacturing facilities at the start of each campaign and periodically during long-running campaigns.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level