QA / QC Technical Specialist, Senior

Overview

USAntibiotics, the only U.S. manufacturer of Amoxicillin products, is part of the Jackson Healthcare family of companies. We're always looking to add new talent to our teams, and we value diverse professionals who have strong leadership skills, align with our culture, and are committed to excellence.

POSITION SUMMARY :

Provide technical support for QA, QC, and TS laboratories. Primary responsibilities include creating validation protocols, equipment validation (IQ, OQ, and PQ), equipment calibration, and manufacturing process troubleshooting, in addition to supporting Annual Product Review documentation. Accurately document all work per written procedures and support improving the efficiency and compliance status of the laboratories.

ROLES & RESPONSIBILITIES :

• Encourages safety first in work practices via guidance from training sessions, chemical hygiene plan, MSDSs (Material Safety Data Sheets), and other technical literature and resources
• Troubleshoots analytical and manufacturing processes and reports problems / resolutions to impacted area.
• Maintain compliance with cGMP and USAntibiotics' standards of safety, quality, and cleanliness.
• Provides statistical support for annual product reviews, special studies, investigations, validation projects, regulatory submissions, etc. as needed.
• Supports activities for the QC Laboratories such as instrument qualifications, calibrations, and maintenance as needed according to schedules, training, and procedures; and provides training to entry and junior level specialists.
• Perform analyst qualification studies, indicating technical proficiency to support troubleshooting analytical testing
• Support any special studies as needed in accordance per protocols and direction of management. Prepares well-documented reports.
• Advises management of any potential improvements, ideas, or changes to methods.
• Completes technical writing as required, e.g., revision of analytical procedures, equipment related SOPs, results summaries, initiates change requests as required. Reviews entry and junior specialists change requests to support the growth and development of the team.
• Evaluates and utilizes state-of-the-art equipment, including automated systems and computerized systems to perform and document testing and meet the goals of improved performance, including reliability and efficiency.
• Assists the Quality unit in meeting goals, business objectives, and production plans.
• Propose ideas for operational changes in QA, QC, and TS laboratory to improve cGMP compliance, efficiency, cost, and performance.
• Create technical documents such as change controls, validation protocols (equipment, facilities, and cleaning), and summary reports.
• Provides oversight, support and mentoring for entry and junior level technical specialist as directed.
• Assists QC Unit in conducting analytical failure investigations following all procedures.
• Keeps current with technical and professional literature and compendia, attending technical discussions, and training opportunities.

QUALIFICATIONS - EDUCATION, WORK EXPERIENCE, CERTIFICATIONS :

KNOWLEDGE, SKILLS, AND ABILITIES :

REQUIRED KNOWLEDGE :

TRAVEL REQUIREMENTS & WORKING CONDITIONS :

EEO Statement :

We are an Equal Opportunity Employer and do not discriminate based on race, color, religion, sex, national origin, age, disability, veteran status, or any other protected status under the law.