Description
The QC Quality Records Specialist III will act as a technical writer and be responsible for the overall management of quality records (deviations, change controls, investigations, CAPA, etc.) and generating GMP protocols/reports within Quality Control. This will include, but is not limited to, initiating quality records within Ascends quality management system (QMS), authoring and ensuring timely completion of the records and assisting in generation of protocol/reports to support GMP studies. Additionally, the incumbent will have the opportunity to interact with cross functional stake holders and 3rd party vendors. This role will report to the Director of Quality Control or designee.Ascend is pioneering the future of healthcare through relentless innovation, our forward-thinking company is on a mission to manufacture safe, efficacious, and scalable gene therapies.
Our vision is to set a new standard for gene therapy manufacturing through continuous scientific and process innovation. Our teams, rooted in biopharma, possess regulatory knowledge and prioritize the quality and potency of manufacturing high-class products. Our goal is to inspire the next generation of experts and breakthrough start-ups in the gene and cell therapy field. With a startup mindset and a track record of rapid growth, we aim to exceed boundaries and achieve continued success. Join us to pursue your passion and make a difference in the industry where there are no limits to what we can achieve.
Requirements
- Initiate, author and drive the closure of quality records (deviations, change controls, investigations, CAPA, etc.) resulting from internal and/or external GMP testing in collaboration with cross functional team including Quality Assurance.
- Participate in the review and/or approval of QC related quality records generated at 3rd party vendors.
- Perform root cause analysis (RCA) to identify the (potential) root cause as part of deviation and/or OOT/OOS investigation.
- Participate in the authoring of SOPs, test methods, study protocols/reports, CoA, etc.
- Participate in the review and/or approval of QC/QA standard operating procedures (SOPs) on behalf of QC.
- Establish, and report on the metrics related to the closure of quality records.
- Participate at the vendor/CTL meetings as a single point of contact (SPOC) for QC related quality records.
- Participate in projects within QC to establish and/or streamline processes.
- Support the team with general QC related activities, as applicable.
- Participate as a subject matter expert (Quality Records SME) during audits and inspections.
- It should be noted that this job description is subject to change at any time.
You will need:
- Minimum of 5 years of QC experience working in a GLP/GMP environment, preferably in a biotechnology company.
- Proficiency in performing root cause analysis using different tools such as 5 Why’s, Ishikawa diagram, FMEA, etc.
- Familiarity with analytical and microbiology test methods, including but not limited to PCR/ddPCR, ELISAs, mammalian cell-based assays, environmental monitoring, bioburden, endotoxin, etc.
- Familiarity with FDA, EMA and ICH guidelines.
- Highly motivated with the ability to work independently and in a team.
- Detail oriented with strong written and verbal communication skills.
- Working knowledge of Microsoft Word, Excel, and PowerPoint.
Benefits
- Annual bonus
- 401k matching up to 3%, 50% on the next 2%
- Medical, Dental, Vision, Life, Short-Term and Long-Term Disability, AD&D, and additional insurances.
- 20 days PTO
- 5 days Sick leave
- 6 weeks Parental Leave
Company Values:
Aim Higher – Our motto and values.
- Quality by integrity - We set high standards, putting quality and evidence first to seek the best solutions.
- Adaptability is in our DNA - We are forward-thinking problem solvers, driven by the developing science and to deliver the best medicines.
- Serving patients by serving our partners - We can depend on each other, and on the organisation, to deliver goals and services.
To start your journey with us at Ascend, kindly submit your resume and a cover letter showcasing your qualifications and interest in the role. We value diversity and oppose discrimination. While we eagerly await all applications, we'll only reach out to selected candidates for interviews. Please note that successful candidates must be legally authorized to work in the United States and will undergo E-verify authentication. Thank you for considering joining our team as we shape the future together!
