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Senior Quality Assurance Technician
2 months ago
About Us
As a prominent entity in the realm of in vitro diagnostics for over five decades, BioFire Diagnostics specializes in delivering diagnostic solutions that identify disease sources and contamination, ultimately enhancing patient health and ensuring consumer safety.
Position Overview
We are seeking a dedicated Senior Quality Assurance Technician to join our Quality Assurance (QA) department, which plays a crucial role in providing quality support across various sectors. This department is structured into specialized subunits, including Reagent Quality, Metrology, Calibration & Preventive Maintenance, Document Control, Quality Auditing, Instrument Quality, Servicing Quality, and Incoming Material QC.
This role is situated within the Reagents Manufacturing Quality Assurance team. The selected candidate will primarily focus on reviewing quality documentation and inspecting manufactured products, while also having the opportunity to engage in other quality-related functions. A commitment to timely and precise work is essential, as this position involves regular collaboration with multiple departments.
Key Responsibilities
- Conduct all tasks in alignment with company policies and adhere to the established Quality System.
- Review, evaluate, and monitor processes and products to ensure compliance with specified requirements.
- Contribute to additional Quality Assurance subunits outside of the primary focus area as assigned.
- Inspect products, including labels, according to specifications and established protocols, determining product acceptance status post-inspection.
- Identify and escalate any non-conformances detected during inspections, collaborating with production teams to address these issues where feasible.
- Maintain rigorous documentation practices during the review of quality documents and records, reporting any inconsistencies to the appropriate systems, and working with production teams to rectify erroneous records.
- Physically release work in progress for the processing of finished goods.
- Organize and archive quality records in accordance with established procedures.
- Prioritize product releases to align with departmental objectives.
- Manage materials suspected of being non-conforming, both physically and electronically.
Qualifications
Education:
- A high school diploma or equivalent is mandatory.
- An associate degree or higher in a life science or engineering discipline is preferred.
- Familiarity with good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is advantageous.
Experience:
- A minimum of one year of relevant on-the-job experience demonstrating professional communication and interaction skills.
- An additional year of experience in a Quality Assurance, Quality Control, laboratory, life science, or manufacturing environment with a formal quality system is required. Education or certification in Quality Management Systems may substitute for this experience.
Skills and Abilities:
- Strong written and verbal communication skills.
- Proficiency in MS Office applications, including Outlook, Word, and Excel.
- General computer proficiency.
- Meticulous attention to detail is critical for this role.
- Ability to accurately follow both written and verbal instructions.
- Organizational skills necessary for managing paperwork and task schedules.
- Proficient in internet navigation.
- Basic mathematical skills.
Physical Requirements:
- Ability to push, pull, bend, and/or lift a minimum of 25 lbs, with the potential to lift up to 50 lbs for extended periods.
- Capability to sit or stand for moderate durations and view computer monitors for extended periods.
- Willingness to travel if necessary, with minimal domestic travel for training purposes.
- Ability to undergo a color-vision test, with results not affecting employment eligibility.
- Capability to perform duties while wearing a Powered Air Purifying Respirator (PAPR) as required.
- Ability to work in a clean room environment, necessitating the use of company-provided and laundered work attire.
