Quality Assurance Technician - US

ROLE SUMMARY
QA Technician provides Quality oversight of Operations (equipment and material preparation, compounding, filling, inspection, and packaging activities) in both aseptic and controlled environments to ensure conformance to established specifications, procedures, cGMPs and regulations. The QA Technician performs readiness walk-throughs, line clearance, in-process checks and verifications in support of manufacturing activities and engages with cross functional teams as needed to support continuous improvement activities, incident investigations and changes.

ROLE RESPONSIBILITIES

Reviews manufacturing related documentation to ensure processes adhereance and compliance with approved SOP’s and cGMPs.

Responsible for performing inspection readiness walk-throughs, line clearance and in-process checks in support of manufacturing activities
Provides QA support for manufacturing and testing activities 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

Able to work in a team environment within own team and interdepartmental teams independently, with minimal guidance and under short timelines while maintaining quality work.
Collects, reports and is responsible for departmental data.

Alerts management promptly to any issues identified during batch production / record reviews that may adversely impact manufactured products, demonstrating accountability and a commitment to maintaining high-quality standards.
Reviews SOPs, Forms, Logbooks, and Master Batch Records to ensure accuracy and compliance with established procedures.

Participates in internal GMP audits and supports customer and regulatory audits.
Assists in training Quality Assurance colleagues.
Has the ability to understand and demonstrate aseptic techniques and behaviors required in aseptic processing areas.
Performs ERP transactions, as applicable.
Must be willing to work overtime and weekends as needed to support business initiatives.

Other tasks assigned by management.

BASIC QUALIFICATIONS

HS/GED. Bachelors degree in a scientific field and industry experience is preferred.
The individual must have strong attention to detail and organizational skills.
The individual must be able to follow instructions and procedures
Basic knowledge of cGMPs (USFDA, Health Canada, PIC/S and/or Eudralex).
Demonstrated decision making ability with emphasis on overall quality, site priorities, results and achievements.
Works well in a team environment within own team and interdepartmental teams.
Must work under short timelines while maintaining quality work.
Must have effective written and oral communication skills.

PHYSICAL QUALIFICATIONS

Position requires vision acuity testing and onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary, short- or long-term basis.
Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications, and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.
The candidate must be able to complete aseptic gowning qualification and work in a Grade A/B classified area
It is required to sit, stand and occasionally lift items (up to ~25 pounds), performing the duties of this position.
Specific vision abilities are required by this job including close vision and color vision. Must achieve a score of 8 or better for near vision (14”) with both eyes, using the Titmus II vision tester, or 20/25 on a near point Snellen acuity card at 16”. Normal color vision confirmed by Ishihara screening.

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