Pharmaceutical Manufacturing Quality Assurance Technician - PEAK Technical Services Inc.

Now hiring experienced Pharmaceutical Quality Assurance Technicians for our client in Portage, IN 

Role Overview: This position collaborates with operations to create, implement, and maintain quality systems that support day-to-day manufacturing activities, ensuring that product and process quality standards are met. You'll provide GMP oversight, perform product testing, troubleshoot quality issues, and coordinate workflows.

Key Responsibilities:

• GMP/GDP Guidance: Ensure proper actions and documentation in the manufacturing space.
• Product Testing: Conduct AQL Testing on finished products, checking appearance, dimensions, printing accuracy, and seal integrity.
• Line Clearances: Perform clearances at all stages of the manufacturing process.
• Record Review: Review and correct real-time documentation to ensure completeness and accuracy. Review and archive pest control documents.
• QA Sampling: Collect and analyze QA samples, documenting results.
• Facility Checks: Spot check and walkthrough facilities to ensure compliance with policies and regulations.
• Problem Solving: Troubleshoot and resolve issues, and create event reports for resolution.
• Support Manufacturing: Understand and support the manufacturing schedule to ensure smooth operations.
• Urgency: Work effectively in a fast-paced environment and manage multiple projects.
• Control Environment: Ensure the manufacturing environment is controlled through building automated systems.
• Audits: Conduct routine audits and ensure readiness for inspections.
• Communication: Report non-conforming events to the Manufacturing Quality Associate, Operations Team Leads, and management.
• Other Duties: Perform additional tasks as needed and participate in special projects.

Qualifications:

• Education: Bachelor’s degree in chemistry, biochemistry, or a related field preferred.
• Experience: 3+ years in the pharmaceutical, biotechnology, or medical device industry with increasing responsibility.
• Knowledge: Understanding of quality systems, GMPs, industry standards, and regulatory requirements.
• Skills: Proficient in reviewing/auditing production records, strong technical writing, problem-solving, and organizational skills.
• Communication: Excellent oral and written communication skills, with the ability to interact at all levels.
• Regulatory Experience: Experience with regulatory agencies is a plus.
• Physical: Ability to lift up to 35 lbs.
• Flexibility: Willing to work off-hours and weekends as necessary.