Description

This is a full-time, non-exempt (hourly) position on the Reagent Quality Assurance (QA) team with an emphasis in the Reagent Training sub-unit. This individual will primarily support task-based training to Reagent Quality Operations members. This position requires a high level of self-direction and motivation. Timely, accurate work is expected. The work is fast-paced, and requires prioritization of daily tasks and attention to detail. Effective communication, written and verbal, is critical. This position regularly interacts and collaborates with other departments within bioMerieux.4x10 Schedule (Wed-Sat, 1 PM – 11:30 PM)
Principal Job Duties and Responsibilities:

• Proficiently:
• Inspect product (including labels) to specifications and established procedures. Determine product acceptance status after inspection.
• Identify and escalate non-conformances observed during inspection. Work with production teams to resolve non-conformances where possible.
• Ensure good documentation practices during quality document and quality record review. Report inconsistent or incorrect records to appropriate systems. Work with production teams to resolve erroneous records.
• Physically release work in process for finished goods processing.
• File and archive quality records according to established processes.
• Prioritize product release to meet department goals.
• Identify and report floor failures observed during sweeps of manufacturing areas.
• Review and approve Device History Records.
• Receive and hold finished goods inventory until release is authorized.
• Release finished goods to stock inventory.
• Coordinate molded part validation inventory.
• Confirm manufacturing equipment meets requirements for release to Manufacturing Engineering for validation.
• Confirm manufacturing equipment meets specifications for release to Reagent Manufacturing for use.
• Control (physically and electronically) material suspected to be non-conforming.
• Review Non-conforming Product Reports (NCRs) for content, accuracy, and clarity.
• Review and decide if rework documentation meets requirements for approval and performance.
• Physically and electronically disposition NCR-related materials.
• Effectively train and mentor QA personnel on Sr. QA Technician duties and responsibilities.
• Plan and coordinate timing of training with respective leaders and other trainers.
• Prioritize training to meet training goals.
• Provide training of Quality Assurance procedures to Sr. Quality Technicians.
• Train or assist with training new hires on required WID’s and retrain existing employees as needed per WID and SOP.
• Determine if personnel training that has been administered is sufficient to ensure consistent execution.
• Determine trainees’ ability to retain knowledge and skills provided throughout a training.
• Communicate progress of assigned trainings to leaders and other trainers.
• Ensure documentation of the job training is completed for each skill as defined.
• Collaborate with other trainers to ensure quality and consistency of provided training.
• Process improvement:
• Draft new procedures and revise existing procedures.
• Collaborate with other teams/departments as necessary to determine appropriate instructions for Quality process.
• Ensure the inputs and outputs of Quality processes are appropriate for processes of other teams/departments.
• Conduct group training sessions for QA personnel on new and revised procedures.
• Design, develop, and implement training curricula.

Education & Experience Requirements:

• High school diploma (or equivalent) is required.
• Associate degree (or higher) in a life science or engineering discipline is preferred.
• Knowledge of good manufacturing practices (e.g., ISO 9001, ISO 13485, and/or 21 CFR 820) is required.
• Enrollment in the Salt Lake Community College Medical Device Manufacturing Program or equivalent (e.g., ASQ certification, Six Sigma certification).
• Minimum 1-year on-the-job experience requiring professional communication and interactions utilizing skills addressed outlined herein.
• Minimum additional 2-year-experience in a Quality Assurance, Quality Control, laboratory/life science or other manufacturing setting with a formal quality system (education in Quality Management Systems may be used in lieu of experience).

Skills & Qualifications:

• Effective communication skills (written and verbal).
• Proficiency in MS Office tools (e.g.Outlook, Word, and Excel) and basic computer navigation.
• Ability to accurately follow written and verbal instructions, as attention to detail is fundamental to this position.
• Basic math proficiency.
• Ability to effectively train, mentor, and coach other team members.
• Ability to collaborate with other team members in order to improve processes and procedures.
• Ability to navigate cross functional discussions, lead meetings, and propose solutions to existing challenges.

Physical Requirements:

• Must be willing to submit to a color-vision test, though result of the test will not determine employment eligibility.
• Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR) as needed.
• Must be able to perform duties in a clean room environment. This requires the use of work attire provided and laundered by the company.
• Must be able to push, pull, bend, and/or lift at least 25 lbs, and may be required to lift up to 50 lbs., for extended periods of time on a daily basis.

Job Type: Full-time

Education:

• High school or equivalent (Required)

Experience:

• Quality Assurance, Quality Control, laboratory/life science: 2 years (Required)

Ability to Relocate:

• Salt Lake City, UT: Relocate before starting work (Required)

Work Location: On the road