Quality Assurance and Document Control Specialist
Quality Assurance and Document Control Specialist
Quantum-Si is pioneering a new generation of technology to create the market of Next Generation Protein Sequencing (NGPS). Similar to Next Generation DNA Sequencing (NGS), which gave us a blueprint of what could happen by studying our DNA, NGPS enables an unbiased view of the proteome through improved scale, resolution, and sensitivity leading to better understanding of disease and improved general health.
We operate at the intersection of biochemistry, chemistry, hardware, molecular biology, photonics, semiconductor chips, and software with a goal to drive a digital transformation of a $44 billion dollar proteomics market.
Join us on the journey to transform healthcare, motivated by the idea that the products you work on will change the lives of millions of people around the world.
The Quality Assurance Specialist is responsible for activities related to the operation and production of goods while achieving speed, quality and cost targets.
As part of our team, your core responsibilities will be:
- Partner with members of quality and manufacturing in batch production activities providing quality guidance of quality issues.
- Responsible for escalation of quality deficiencies identified in the production process
- Assist in development, implementation and maintenance of quality systems and other QA activities.
- Maintains and monitors key quality systems such as deviations, investigations, CAPA; review of trended data to identify improvements.
- Performs reviews of internal and external batch documentation, records and reports.
- Review QC data generated as to the acceptance to established product specifications.
- Coordinate the review of procedures, specifications, and forms.
- Prepare status reports and review documents for accuracy and completeness.
- Manage files for all Company Standard Operating Procedures (SOPs)
- Facilitates document reviews for certifications and inspections.
- Maintains active files for all QC investigations.
- Bachelors degree of Science in biological sciences or a related field
- Three to five years of experience in a manufacturing environment
- Experience performing raw materials, in-line and finished product inspections.
- Experience assisting with investigations, root cause analysis, and reports.
- Maintenance of validation documentation through the validation lifecycle
- Troubleshooting in the event of abnormal testing results
- Ensuring accurate records of all validation activities.
You Deeply Identify with Core Quantum-Si Values:
- Team: We are stronger as a unit and collectively committed to the goal and each other.
- Accountability: Be accountable to the goal, the team and yourself.
- Passion: We are enthusiastic and dedicated to expanding scientific understanding and its impact.
- Excellence: Be aggressive and have a sense of urgency but take pride in each task taken on.
- Transparency: We align as an organization and communicate success and challenge.
- Competitive: We do not fear but learn from making mistakes. We play to win!
- Diversity: Each individual regardless of role makes a difference and impacts our progress.
We offer great perks:
- Competitive salaried compensation – we value our employees and show it
- Equity – we want every employee to be a stakeholder
- Fully covered medical insurance plan along with a generous company sponsored health reimbursement account, and dental & vision coverage – as a health-tech company, we place great worth on our teams’ well-being
- Company paid life insurance, short term and long term disability
- Flexible Paid Time Off – personal responsibility for managing our own time, workload and results plus 14 paid holidays inclusive of MLK Day, Juneteenth, Indigenous People’s Day and Veterans Day
- Parental Leave – we provide a generous 10 week parental leave and additional 6-8 weeks pregnancy related leave for birthing parents
- Pre-tax commuter benefits – we make your commute more reasonable
- Free onsite meals
- 401k plan – we facilitate your retirement goals
- Beautiful office in the heart of San Diego
- The opportunity to build a revolutionary healthcare product and save millions of lives!
The estimated base salary range for this role based in the United States of America is: $75,000 – $115,000. Compensation decisions are dependent on several factors including, but not limited to, level of the position, an individual’s skills, knowledge and abilities, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all full-time employees are eligible for our discretionary bonus program and equity as part of the compensation package.
Quantum-Si does not accept agency resumes.
Quantum-Si is an E-Verify and equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.