Manager – QA/QC
Codagenix Inc. is a clinical-stage synthetic biology company that uses software to recode the genomes of viruses, constructing live-attenuated vaccines or viruses to prevent viral infections or treat solid tumors. Codagenix’s recoded vaccine candidates are a perfect antigenic match to the target virus and induce a robust immune response to all viral antigens. Our nimble platform allows us to turn a virus into a potential prophylactic vaccine.
The Manager, QA/QC will oversee, participate in, and manage all Quality Assurance (QA) and Quality Control (QC) activities. Responsibilities include working collaboratively across internal functions including Manufacturing, Analytical/Process Development, Regulatory Affairs, and Supply Chain to ensure QA deliverables are met. Act as a point of contact (POC) on QA matters, internally and externally. This position is onsite at Codagenix headquarters in Farmingdale, NY.
- Review and approve master and executed GMP documentation including production records, testing records, deviations, investigations, reports, protocols, change controls, SOPs and CAPAs.
- Prepare lot release documents, including certificate of analyses (CoAs) for final management approval. Ensure resolution of all identified issues prior to lot disposition (e.g. investigations, deviations).
- Act as first responder for on the floor quality issues in a timely manner, assists in the documentation of events and identifying required containment/corrective actions as appropriate.
- Assist in the tracking and reporting of lot disposition status to management and other stakeholders.
- Write technical documents such as reports, change controls, and SOPs. Includes reviewing and approving these document types.
- Ensure work is conducted following cGMP requirements and stay current as subject matter expert for changes in GXP expectations, including FDA, EU and other relevant foreign regulatory bodies, guidance documents (i.e.: ICH, PTC, ISPE, etc.), and best industry practices.
- Communicate and collaborate cross-functionally to resolve technical issues in accordance with appropriate quality standards.
- Participate in audits as needed (internal, regulatory, and/or partner).
- Bachelor of Science degree / equivalent in life sciences or related field.
- 6-12 years of experience in Quality Assurance with at least 3 years in a GMP environment or FDA regulated industry.
- Experience with QA oversight of Contract Development and Manufacturing Organizations.
- Strong knowledge of FDA and ex-US regulations in development through commercial.
- Fluency with regularly used Microsoft software applications (Word, Excel, PowerPoint, SharePoint).
- Skilled in design and deployment of QA programs and procedures.
- Ability to solve complex technical issues and drive to closure.
- Strong interpersonal and leadership skills including a flexible, collaborative, and team-oriented approach to problem solving and an ability to work in a fast-paced, rapidly changing environment.
- Ability to manage multiple priorities with a sense of urgency to meet timelines.
- Excellent communication skills both verbal and written.
Please email CV and cover letter to [email protected]
Note: Candidates for this position must be currently authorized to work in the United States on a full-time basis, and Codagenix will not sponsor applicants for work visas. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
Codagenix is an equal opportunity employer and values diversity. All employment decisions are made on the basis of qualifications, merit and business need.