Quality Assurance Technician - US
About The Position
The Quality Assurance Technician provides quality oversight of operations—including equipment and material preparation, compounding, filling, inspection, and packaging—in aseptic and controlled environments. The role ensures conformance with established specifications, procedures, current Good Manufacturing Practices (cGMPs), and regulations. The technician performs readiness walk-throughs, line clearances, in-process checks, and verifications to support manufacturing, and works with cross-functional teams on continuous improvement, incident investigations, and changes. The position requires onsite attendance and cannot be performed remotely or by telecommuting. The technician must be able to complete aseptic gowning qualification and work in a Grade A/B classified area. The role may require overtime and weekend work to support business initiatives.
Requirements
- High school diploma or GED.
- Strong attention to detail and organizational skills.
- Ability to follow instructions and procedures.
- Basic knowledge of cGMPs, including USFDA, Health Canada, PIC/S, and/or EudraLex requirements.
- Demonstrated decision-making ability emphasizing overall quality, site priorities, results, and achievements.
- Ability to work well in a team environment, including interdepartmental teams.
- Ability to work under short timelines while maintaining quality.
- Effective written and oral communication skills.
- Ability to complete aseptic gowning qualification and work in a Grade A/B classified area.
- Ability to multitask across capabilities and functions, handle competing priorities, respond to frequent email and phone communications, and attend meetings and conference calls, including activities that may extend beyond core hours or time onsite.
- Ability to sit, stand, and occasionally lift items up to approximately 25 pounds.
- Required vision abilities include close and color vision. Must achieve a score of 8 or better for near vision at 14 inches using a Titmus II vision tester, or 20/25 on a near-point Snellen acuity card at 16 inches; normal color vision must be confirmed by Ishihara screening.
- Must undergo vision acuity testing and attend onsite.
Nice To Haves
- Bachelor's degree in a scientific field.
- Industry experience.
Responsibilities
- Review manufacturing documentation to ensure adherence to processes and compliance with approved SOPs and cGMPs.
- Perform inspection readiness walk-throughs, line clearances, and in-process checks in support of manufacturing.
- Provide QA support for manufacturing and testing, including shop-floor oversight, deviation and laboratory investigations, change management, SOP revisions, and batch-documentation review.
- Proactively identify and address non-conformances in manufacturing operations.
- Work independently with minimal guidance and collaborate with own and interdepartmental teams while meeting short timelines and maintaining quality.
- Collect, report, and take responsibility for departmental data.
- Promptly alert management to issues identified during batch production or record reviews that may adversely affect manufactured products.
- Review SOPs, forms, logbooks, and Master Batch Records for accuracy and compliance with established procedures.
- Participate in internal GMP audits and support customer and regulatory audits.
- Assist in training Quality Assurance colleagues.
- Understand and demonstrate aseptic techniques and behaviors required in aseptic processing areas.
- Perform ERP transactions, as applicable.
- Work overtime and weekends as needed to support business initiatives.
- Perform other tasks assigned by management.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
