QA Specialist II (M-F 3:00pm-11:30pm)
Genezen
Summary
In support of biologics/gene therapy manufacturing operations, the Quality Assurance Specialist II engages in collaborative day to day floor support and batch record review which ensures timely and compliant batch disposition. This role is accountable for all elements of the Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), change controls, and upholding data integrity. This role is aligned with the Manufacturing 2nd shift and the schedule is Monday-Friday, 3pm-11:30pm.
Job description
Job Summary
In support of biologics/gene therapy manufacturing operations, the Quality Assurance Specialist II engages in collaborative day to day floor support and batch record review which ensures timely and compliant batch disposition. This role is accountable for all elements of the Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), change controls, and upholding data integrity. This role is aligned with the Manufacturing 2nd shift and the schedule is Monday-Friday, 3pm-11:30pm.
Essential Job Functions
- Oversee and provide compliance guidance during on-the-floor manufacturing activities.
- Work alongside manufacturing teams to ensure current and best practices are implemented.
- Support cGMP manufacturing operations through administration and enforcement of the Quality Management System including, but not limited to, deviations, change controls, and CAPAs.
- Review and approve executed batch records, solution lot records, and logbooks.
- Participate in batch disposition activities.
- QA support of drug product aseptic fill operations and vial visual inspections.
- Assist in deviation investigations.
- Support internal and external audits and inspections.
- Support continuous improvements.
Special Job Requirements
- Adaptability required as work schedule may change based on business needs.
- Criminal background check required.
- Other duties as assigned.
Knowledge, Skills and Experience
- BS in science or engineering discipline
- Desired 3-5 years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment
- Experience working in a cGMP manufacturing environment
- Well versed in cGMP/ICH/FDA/EU regulations and guidelines
- Proficient in using Microsoft applications (MS Outlook, MS Teams, MS Word, MS Excel, MS PowerPoint etc.)
- Strong written and verbal communication skills to interact with cross function teams
- Strong organizational skill
- High level of attention to detail
- Good problem-solving skills
- Capable of working with minimal supervision
- Ability to work well with diverse groups
- Ability to multi-task in a fast-paced environment with challenging timelines
Requirements
- BS in science or engineering discipline
- 3-5 years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment
- Experience working in a cGMP manufacturing environment
- Well versed in cGMP/ICH/FDA/EU regulations and guidelines
- Proficient in using Microsoft applications (MS Outlook, MS Teams, MS Word, MS Excel, MS PowerPoint etc.)
- Strong written and verbal communication skills to interact with cross function teams
- Strong organizational skill
- High level of attention to detail
- Good problem-solving skills
- Capable of working with minimal supervision
- Ability to work well with diverse groups
- Ability to multi-task in a fast-paced environment with challenging timelines
Benefits
- Paid Vacation Days
- Paid Sick Time
- 10 Observed Holidays
- 2 Floating Holidays
- 1 Volunteer Day
- 401(k) Matching
- Share Appreciation Rights
- Healthcare Plans
- FSA Program
- HSA Program
- Dental & Vision Care
- Employer-Paid Life Insurance
- Voluntary Disability Insurance
- AD&D Insurance
Company overview
Genezen is a leading contract development and manufacturing organization (CDMO) specializing in viral vector manufacturing for gene and cell therapies. Founded in 2014 and headquartered in Lexington, Massachusetts with additional facilities in Indianapolis, Indiana, the company provides comprehensive CDMO services across multiple vector modalities including lentiviral, retroviral, and adeno-associated viral (AAV) vectors. With over a decade of experience in the cell and gene therapy space, Genezen offers end-to-end solutions from process development and analytical testing to cGMP manufacturing and commercial production. The company operates state-of-the-art facilities totaling over 146,000 square feet of cGMP-compliant manufacturing space and holds multiple global regulatory licenses from agencies including the FDA, EMA, Health Canada, and MFDS Korea. Genezen partners with both early-stage biotech companies and established pharmaceutical organizations to accelerate the development and commercialization of potentially life-saving therapies, with a particular focus on oncology, rare diseases, and other complex medical conditions requiring advanced gene and cell therapy approaches.