QA Specialist - Remote

The Quality Specialist participates the day to day management and operations of the facility, products and vendors. Through outstanding communication, effective problem solving, and active management of ambiguous situations, the Quality Specialist 3 ensures safety, quality and compliance with all relevant procedures, state and federal regulations and customer expectations. Ensures smooth and safe operations of the storage facility through stakeholder and vendor engagement.

PRIMARY RESPONSIBILITIES:

• Collecting and trending quality metrics
• Work to assign IDs for CAPAs, Deviations, SCAR, Complaints, and NCRs and filing completed records.
• Partner to provide review and approval of quality records
• Participate in Quality System related meetings (as needed)
• Assist with obtaining documentation and supporting the team during audits
• Work to help schedule Internal Audits
• Stays current on applicable regulation and guidance from FDA, ISO13485, CLIA, CAP, etc
• This role works with PHI on a regular basis both in paper and electronic form and has access to various technologies to access PHI (paper and electronic) in order to perform the job.
• Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
• Must maintain a current status on Natera training requirements.
• Employee must pass post offer criminal background check.
• Performs other duties as assigned

QUALIFICATIONS:

• Bachelor’s Degree in Life Sciences, Engineering, Software or equivalent
• 1+ year of working experience in Biotech industry preferred or a relevant combination of skills, education, and experience

KNOWLEDGE, SKILLS, AND ABILITIES:

• Independent and self-starter with organizational and planning skills
• Excellent written and verbal communication
• Interpersonal skills are desired with the ability to be flexible and collaborate with others
• Ability to use Microsoft …