Document Control/QA Specialist
miRagen Therapeutics, Inc. is a clinical stage biopharmaceutical company developing proprietary RNA-targeted therapeutics with a specific focus on microRNAs and their role in diseases where there is a high unmet medical need. Using our expertise in RNA-based therapeutics and systems biology, we have created a diverse pipeline of RNA-targeted product candidates.
We are a growing Boulder-based organization seeking a Document Control/QA Specialist to work with our Quality Assurance and Regulatory team. The position is a hands-on role that will support QA efforts while developing and maintaining all facets of the Company’s document control system. Primary responsibilities include:
- Maintain document management system, including quality documentation, scientific reports, training records and regulatory documentation
- Generate and/or revise GMP and other documentation such as standard operating procedures
- Review and edit clinical, nonclinical and/or technical reports and regulatory documents as requested
- Maintain employee training system and associated training records
- Maintain, review and approve manufacturing, packaging, and analytical records/data to ensure consistency with company policies and specifications necessary for batch release of clinical and commercial intermediates, and drug products intended for human clinical studies
- Maintain quality systems and procedures compliant with regulatory standards such as deviation, CAPA and MRB systems
- Review and approve labeling and packaging specifications, master records, and change control
- Track and maintain stability protocols and associated stability data for drug product and/or intermediates, including stability tables for regulatory submissions
- Review contractor investigations, deviations, and complaints; initiate necessary records according to company procedures
- Maintain the Vendor Qualification program including CRO/CMO quality agreements, approvals, and audit reports
- Work closely with Regulatory, CMC, contractors, and internal stakeholders to prioritize documentation review and product release
Bachelor’s degree in Life Sciences or related field and 3+ years of relevant QA experience in a FDA regulated environment. QA experience pertinent to the GMP manufacturing of oligonucleotides preferred but not required.
Required Skills and Knowledge:
- Strong working knowledge of Quality Management Systems and GMP standards applicable to human clinical drug products.
- Experience with electronic document management.
- Demonstrated ability to manage quality initiatives with external contractors such as CMO’s and CRO’s.
- Strong time-management and organizational skills, and the ability to multitask in a fast paced environment.
- Excellent verbal and written communication skills, and the ability to work effectively in a cross-functional team environment.
- Ability to work independently and manage shifting priorities while maintaining accuracy and quality.
- Strong analytical and critical thinking abilities.
- Exceptional computer skills including Microsoft Office software.
Interested candidates should email a cover letter and resume in PDF format to email@example.com