Manufacturing Quality Associate (2nd or 3rd Shift Available)

Job Summary

The Manufacturing Quality Associate ensures quality and compliance during manufacturing operations by collaborating with various functions to support product quality.

Responsibilities

• Maintains adherence to AQST policies and procedures, providing guidance and clarity to colleagues.
• Conducts routine internal audits and facility walkthroughs to ensure compliance with internal quality system requirements.
• Initiates and investigates nonconformances, managing resolution through partnerships with other functions.
• Authors and reviews Forms, Batch Records, WI, SOPs, Protocols in electronic document management system.
• Investigates product quality complaints using knowledge of manufacturing and quality processes.
• Owes CAPA records and action item implementation, working with operations, supply chain, engineering, and QC staff.
• Coordinates the Environmental Monitoring program, including third-party water testing, sampling, and report generation.
• Performs AQL Testing on finished product, verifying attributes such as product appearance, dimensions, printing, and seal integrity.
• Performs line clearances for all steps of the manufacturing process.
• Maintains QA Retain Program, including sampling, inventory management, and inspections.
• Leads process for ensuring manufacturing environment is in a state of control through evaluation of building automated system software.
• Determines, documents, and communicates when facilities can be released back to cGMP operations after shutdowns or environmental excursions.
• Performs real-time review of operational records, assisting in obtaining required corrections.
• Operates with a sense of urgency in a fast-paced environment.
• Performs off-hour and weekend work as necessary.

Qualifications

• BS degree in chemistry, biochemistry, or related science field, or equivalent experience.
• 2+ years of related experience in pharmaceutical, biotechnology, or medical device industry.
• Demonstrated knowledge of quality systems, GMPs, industry standards, and regulatory requirements.
• Formal training in Quality disciplines (certified ASQ, Lean Six Sigma, etc.) preferred.
• Technical proficiency in reviewing/auditing production records, reports, and GMP-related documentation.
• Team player with the ability to lead project teams and manage multiple assignments.
• Highly organized, detail-oriented, excellent communication skills, and ability to interact at all levels.
• Willingness to work off-hour shifts and weekends as necessary.