About us:
Emmecell is a growing, clinical-stage cell therapy company whose mission is to bring innovative regenerative medicine in ophthalmology out of the laboratory and into patient care.
We are seeking an enthusiastic and talented Quality Assurance Specialist. In this role, you will work as part of a fast-paced team in a GXP environment.
Primary Responsibilities include:
- Review and approval of cGMP documents such as SOPs, specifications, and reports.
- Review and approval of completed batch production records for product release.
- Impact analysis and implementation of changes that affect Quality.
- Document control
- Conduct Quality on the Floor activities, including quality walk-throughs of the production, testing and storage areas.
- Provide Quality support to Manufacturing personnel on the floor; provide guidance during GMP events and initiation of deviation investigations.
- Review deviations, product non-conformities, and GMP investigations.
- Support manufacturing operations throughout the entire manufacturing process.
- Review and approval of incoming raw materials, routine preventive, and calibration of equipment.
- Support internal and external audits, including documenting observations and implementation of corresponding CAPAs.
- Train and mentor junior team members.
- Coordinate release final cell-based therapeutic products for clinical applications.
- Review and approve validation and qualification packages including installation, operation, and performance qualifications (IQ, OQ, PQ) protocols and reports as necessary.
- Train and provide QA guidance to internal functional groups on Quality Systems.
- Provide environmental monitoring and other QC support as needed
Education and Experience:
- Bachelor’s degree in a relevant science or engineering discipline is preferred.
- 3-5 years of relevant experience in cGMP and cell therapy is required.
- Project management experience is preferred.
Skills:
- Proficient use of Microsoft Suite (Word, Excel, PowerPoint), GSuite, Adobe Suite, and ability to quickly learn and master new computer programs and automate data entry tasks.
- Attention to detail with effective planning, organization, and execution skills.
- Excellent written and verbal skills with a background in English instructions, scientific writing.
Emmecell is an equal opportunity employer committed to nondiscrimination for all employees and qualified applicants without regard to a person's race, color, gender, gender identity, pregnancy, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest; however, only those selected will be invited for an interview.
