QA Specialist

GenScript

  • Redmond, WA
  • $56,200-80,000 per year
  • Permanent
  • Full-time
  • 1 day ago
About GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.About ProBioProBio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy, vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing.Role Description:The Manufacturing QA Specialist role is to ensure that end-products are meeting quality pre-established standards, through inspecting and monitoring both incoming materials, end products, procedures and processes.Key Responsibilities:
  • Inspecting products or materials at various stages of the manufacturing process to ensure they meet specific requirements;
  • Reviewing CoAs and Releasing outgoing products;
  • Releasing incoming critical materials;
  • Continuously working into meeting departments metrics (KPIs);
  • Submitting monthly performance related data to the manager;
  • Contributing in cross-department efforts for process continuous improvements (process flow, manufacturing electronic systems (MES);
  • Participating in implementation of 5S program in production lab area;
  • Inspecting procedures in use in production area for compliance to effective versions;
  • Performing On-Site QA walks in production area and identify opportunities of improvement;
  • Identify any non-conformity and escalate to QA and production teams for resolution;
  • Periodically reviewing batch records and ensuring continuous good documentation practices (GDP);
  • Distributing controlled documents to production and removing obsolete versions;
  • Archiving QMS documentation related (SOPs, training records, forms, logbooks, lab notes books);
Qualifications:
  • Bachelor's degree in the scientific discipline of molecular biology, chemistry, biochemistry, pharmaceutical science, chemical engineering or related field.
2 years of relevant experience in Quality Assurance or Quality Control experience in a ISO9001/ or GMP manufacturing environment will be prioritized. * Excellent written and verbal communication skills with internal peers and managers
  • Individual may be required to sit, stand, walk regularly in production area, and occasionally lift 0-15 pounds.
Benefit:
  • Medical Insurance/ Vision Insurance/ Dental Insurance
  • 401(k) & Retirement Savings Plan (RSP)
  • Short Term Disability Insurance
  • New Child Leave
  • Paid Time Off
  • Paid Company Holidays per year
  • Paid Sick Days (earned based on hours worked)
  • Compassionate Leave
  • Jury Duty Leave
  • Float day
  • Personal days
Perks:
  • Free colleague meals during shift
  • Onsite massages Charis
  • Onsite gyms
Compensation:
Salary range: $56,200 - $80,000, depending on experience and qualifications.GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

GenScript