Quality Assurance Specialist III

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.


JOB SUMMARY

Quality Assurance Specialist III is responsible for supporting multiple programs or supporting the coordination of the quality systems, but not necessarily both. The Quality Assurance Specialist III will be responsible for ensuring that adequate QA support is provided for the cross functional IPT meetings and customer teleconferences.

Works under only general direction.

DUTIES AND RESPONSIBILITIES

• Communicates the status of QA-related items to the IPT Team, including batch release and investigation status.
• Takes an active role in providing, as appropriate, guidance within the approved systems and procedures as it relates to GMP production and release of products, some of this guidance may be required outside of the typical working schedule (off shift).
• Responsible for taking an active role in the planning and execution of action items related to the support of production and product release, including document control and production record review activities.
• Manages the release of products to support subsequent production and release of products to customers within the 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 of the validation and qualifications are adequately presented in approved reports.
• Responsible for facility audits of the respective manufacturing facilities at the start of each campaign and periodically while long-running campaigns are active.

REQUIREMENTS

EDUCATION AND EXPERIENCE

• 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.
• Bachelor's degree preferred in an appropriate science.
• 5 years of related technical experience or equivalent combination of education and experience.

COMPETENCIES/SKILLS

• Ability to act with a sense of urgency, while maintaining accuracy and data integrity.
• Ability to work in a face paced, team-oriented environment.
• Strong attention to detail.