Description
Job Title:
Quality Assurance Coordinator
Location:
San Diego, CA / Hybrid / Remote
Position type:
FLSA:
Full time
Exempt
Department:
Regulatory and Quality
Strive to Bring a Profound Difference to our Patients
At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people's lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients.
Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™). Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is broadening the reach of AOCs with its advancing and expanding pipeline, including programs in cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline, and people, please visit www.aviditybiosciences.com and engage with us on LinkedIn and Twitter.
The Opportunity
The QA Coordinator position is to support Company's audit program and Quality Management Systems. The individual will be responsible for establishing and updating the audit schedule (internal and external), assist in scheduling the audits, tracking audit responses and corrective actions, and closure of audits. The QA coordinator will maintain the audit logs and Approved Vendor List, and manage the processing and filing of audit records and documents. The individual will also support quality assurance processes, initiatives, and continuous improvement of Quality Management Systems, including the handling and tracking of quality events, CAPA, Change Controls, and Quality Agreements.
What You Will Contribute

• Work with appropriate QA team members in establishing annual GxP audit schedule and assist in scheduling audits.
• Update and regularly maintain the audit schedule and tracker.
• Work with cross-functional teams in obtaining vendor qualification information and documents.
• Organize and maintain audit documents and files, follow up on audit responses, and ensure audits are completed and closed timely.
• Provide support for all quality system activities, including tracking status of quality events and topics.
• Follow up with cross-functional teams and stakeholders for requested information.
• Gather data, run reports, and compile key process indicators (KPI).

What We Seek

• BS in Life Sciences or related field.
• 1-3 years of relevant work experience in the bio/pharmaceutical industries.
• Experience in data handling and documentation.
• Experience in tracking and following up on tasks and projects.
• Ability to multi-task, including working independently and as part of a team.
• Positive and professional attitude with excellent communication and writing skills.
• Excellent organizational, prioritization, and effective decision-making skills.
• Proficient with Microsoft Office MS Office (Excel, Word, PowerPoint), Adobe Acrobat, etc.

What We will Provide to You:

• The base salary range for this role is $56,800 - $62,800. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
• Avidity offers competitive compensation and benefits which includes the opportunity for annual and spot bonuses, stock options and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off.
• A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.

Avidity Biosciences
10578 Science Center Dr. Suite 125
San Diego, CA
92121
O: 858-401-7900
F: 858-401-7901