Quality Assurance Specialist

Genocea Biosciences, Inc. Cambridge , MA 02138

Posted 2 months ago

Position Summary

We are looking for a Senior Quality Assurance Specialist to support quality assurance activities in support of the manufacture, testing, and release of clinical product. The QA Specialist will review manufacturing batch records, deviations, change controls and disposition of clinical drug product. The Senior Quality Assurance Specialist is responsible for ensuring reviews of Manufacturing and Quality Assurance records are compliant with in-house specifications/standards and Good Manufacturing Practices. In addition, the Sr. QA Specialist will work to identify key continuous improvement opportunities to ensure phase appropriate quality systems are aligned with business strategy, industry standards and global regulatory expectations.

Primary Responsibilities

  • Reviews manufacturing and support records to confirm compliance with specifications and procedures

  • Assists Quality Assurance Management with product disposition activities.

  • Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending

  • Works closely with Manufacturing and Analytical to resolve open issues resulting from record reviews and deviation issues

  • Work with all departments to ensure timely completion of manufacturing batch records, deviations, CAPAs, and change controls

  • Input batch/lot information into electronic databases

  • Review Manufacturing batch records and completes required documentation for batch disposition

  • Create, revise and review Quality System documents, including Standard Operating Procedures, protocols, and reports

  • Performs data audits, as needed

  • Provide training to site personnel and contractors on GMP and quality system procedures, as needed

  • Vendor oversight and management

Competencies

  • Ability to prioritize daily activities in order to meet timelines in a fast-paced environment

  • Ability to monitor and report on assigned tasks, goals and objectives

Education and Experience Requirements

  • Bachelor's degree in Life Sciences, or related field and 5 to 8 years' experience in biopharmaceutical quality assurance

  • Excellent written and verbal communication skills

  • Experience with clinical product programs is required

  • Experience personalized medicine or cell therapy products is a bonus

We aim for a high-performing and collaborative culture that embraces diversity, equity and inclusion as a source of strength

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Quality Assurance Specialist External Quality Ocular

Editas Medicine

Posted 3 days ago

VIEW JOBS 11/20/2020 12:00:00 AM 2021-02-18T00:00 <p>What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.</p> <p>Editas is seeking a highly motivated and experienced quality professional to manage the quality activities at contract manufacturing organizations (CMOs) and Contract Testing Organizations (CTOs) and to serve as the Quality Lead for external partnerships. This position will be responsible for managing all activities associated with product disposition and release testing at CMOs and CTOs. The ideal candidate will have experience in the Biopharmaceutical industry in QA and QC.</p> <p>Responsibilities will include:</p> <ul> <li>Provide QA leadership for Ocular programs and the QA Ocular team</li> <li>Act as QA Lead for tech transfer, process development, and process validation for Editas Ocular programs</li> <li>Quality Assurance Lead for external collaborations to provide quality system expertise and help identify solutions and ensure compliance to GMP</li> <li>Author, review and approve GMP documentation (SOPs, batch records, protocols, technical reports, test methods, protocols, specifications, and summary reports to support GMP manufacturing).</li> <li>Support External Quality partnerships as required in the initiation and follow up of deviations, CAPAs, and change controls.</li> </ul> <ul><li>Build on relationships within our CTOs and CMOs ensuring issues impacting quality control testing are tracked and resolved in a timely manner.</li></ul> <ul> <li>Responsible for compliance with documentation management system (quality agreements, CMO performance evaluations, master batch records, analytical data, etc.).</li> <li>Support projects, and global processes alignment (internal and external) as well as continuous improvement and initiatives.</li> <li>Review executed batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, and that all limits and specifications have been met.</li> <li>Review and approve deviations, change controls and CAPAs for appropriateness, completeness and to meet internal procedures and regulatory expectations.</li> <li>Work collaboratively with cross functional teams, partners, and vendors to gather background knowledge needed to complete assignments.</li> <li>Develop and maintain Quality Agreements with contract manufacturers, suppliers, and laboratories</li> <li>Independently coordinates complex investigations in cross-functional areas.</li> <li>Anticipate issues and escalate to appropriate management attention immediately.</li> <li>Exercises judgment in resolving moderate to complex quality issues.</li> <li>Plan and execute work independently and consult with supervisor as needed.</li> <li>Supports the organization in maintaining inspection readiness.</li> <li>Review and approve validation protocols and reports to ensure compliance</li> <li>Review analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans</li> <li>Support generation of metrics for Management Review</li> <li>Review stability protocols and reports</li> <li>Conduct internal and external audits as required, track progress, and trend results</li> <li>Occasional travel will be required </li> </ul><p><strong>Requirements</strong></p><ul> <li>A Bachelor’s or Master’s degree in biology, chemistry or other life science and at least 7 years of relevant industry experience in Quality Assurance in a Pharmaceutical/Biotech GMP environment</li> <li>A solid understanding of applicable regulations and guidelines pertaining to pharmaceutical product development. manufacturing, testing and clinical operations </li> <li>Experience with GMP’s in a working manufacturing environment strongly preferred</li> <li>A working knowledge of GMP requirements for Clinical Trial Material in both the US and EU including sterile manufacturing strongly preferred</li> <li>Certified Quality Auditor (CQA) would be a plus</li> <li>Investigational skills including Root Cause Analysis and Product Impact Assessments</li> <li>Ability to manage multiple projects with minimal oversight in and evolving environment</li> <li>Strong communicator and collaborator who possesses a flexible approach to problem solving and ability to apply risk-based decision making</li> </ul> Editas Medicine Cambridge MA

Quality Assurance Specialist

Genocea Biosciences, Inc.