Kephera Diagnostics is a startup that aims to address the public health challenges of global infectious diseases with new point of care assay technology. Our mission is to promote more effective and more affordable medical treatment through faster, point-of-care diagnosis. We collaborate with a global community of researchers to develop and translate new technologies into accessible products for clinical diagnostics and research applications. Kephera has recently been funded for development of new tests for several infectious diseases of global significance.

Kephera seeks a motivated, entrepreneurial individual for the position of Quality Assurance Associate, to be responsible for QA for the company’s operations and CLIA laboratory.

The QA associate will participate in development and application of the quality management system, assist in internal audits, schedule QA related events, assist with regulatory affairs documentation and participate in creation and implementation of control procedures.

Responsibilities:

• Participate in development of quality management system and document control
• Quality assurance documentation for daily lab and company operations
• Participation in regulatory affairs documentation
• Assist in document writing, review, and formatting
• Documentation management, maintenance, and archiving
• Ensure compliance with documented policies and procedures
• Assist with managing the training program and periodic compliance functions
• Support internal and external audits and regulatory inspections, as required.
• Identify gaps in systems and procedures
• Perform other tasks as assigned.

Qualifications:

Primary skills and knowledge required include, but are not limited to the following:

• 1-3 years in quality assurance in medical devices or bio/pharma
• Experience with regulatory affairs documentation desirable
• Laboratory experience (preferred)
• Working knowledge of 21 CFR 820 QSR, ISO 13485, ISO 14971, CLIA regulations (preferred)
• Bachelor's degree or higher
• Self-motivated individual with a desire to expand QMS knowledge.
• History of developing and maintaining controlled procedures.
• Proven ability to work in an extremely fast-paced, dynamic environment
• Must be a team player with good interpersonal skills
• Excellent problem-solving, organization and communication skills.
• Proficient in Microsoft Office Suite

Kephera offers a dynamic start-up environment combining flexibility, challenging work and the opportunity to participate in a new venture aimed at improving global public health. Kephera’s location in downtown Framingham offers free parking and commuter rail accessibility. Kephera is committed to a diverse workplace.

Job Type: Full-time

Pay: $32.00 - $42.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Paid time off

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Framingham, MA 01702: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• Quality assurance: 1 year (Preferred)

Work Location: In person

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