Sr. QA Specialist (Fri-Sun 6am-6:30pm)

Genezen Inc.; Lexington (MA); Hybrid; USD 100,000 - 115,000; Full time

Benefits offered by this job

Paid vacation days

401(k) with company match

Healthcare plans

FSA/HSA programs

Life insurance

Disability insurance

Job summary

Genezen Inc. is seeking a Senior QA Analyst to champion regulatory compliance on the manufacturing floor in Lexington, MA.

You will lead the Quality Management System, manage deviations and CAPAs, and review critical manufacturing documents to ensure product quality and regulatory readiness. You will collaborate with cross-functional teams, perform batch dispositions, and provide QA support for aseptic fill operations while mentoring junior staff.

Qualifications

• 8+ years of GMP experience in pharma/biotech with a regulated GMP environment.
• Experience in cGMP manufacturing and adherence to FDA/ICH/EU guidelines.
• Strong written and verbal communication and cross-functional collaboration.
• Proficient in Microsoft Office applications (Outlook, Word, Excel, PowerPoint).
• Capable of working with minimal supervision in a fast-paced setting.

Responsibilities

• Oversee QA regulatory compliance on the manufacturing floor.
• Administer QMS activities including deviations, CAPAs, change controls.
• Review and approve Manufacturing documents (SOPs, batch records, logs).
• Perform QA walkthroughs to maintain inspection readiness.
• Support batch disposition and aseptic fill operations.

Skills

GMP/CGMP compliance

CAPA investigations

Deviation management

QMS ownership

Document review/approval

Regulatory liaison

Training & mentorship

Data integrity

Education

BS in science or engineering

Tools

MS Office

Job description

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

WORKING AT GENEZEN

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.

JOB SUMMARY

In support of biologics/gene therapy manufacturing operations, the Senior Quality Assurance Specialist champions collaborative day to day floor support, batch record review, and 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), excursions, Out of Specifications (OOS), change controls, and upholding data integrity.

This role is aligned with the Manufacturing Friday-Sunday shift and the schedule is Friday-Sunday, 6am-6:30pm.

ESSENTIAL JOB FUNCTIONS

• Oversee and provide regulatory compliance guidance during on-the-floor manufacturing activities.
• 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 documents from Manufacturing, such as SOPs, batch records, logbooks, training forms, etc.
• Perform Quality walkthroughs to maintain inspection readiness environment.
• Participate in batch disposition activities.
• QA support of drug product aseptic fill operations and vial visual inspections.
• Assist in deviation investigations, CAPA and Change Control implementations.
• Provide QA operation functional trainings, guidance, and mentorship to junior QA specialists.
• Support internal and external audits and inspections.
• Lead and support the Quality and production operation continuous improvement.

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

8+ 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 ect.)

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 Essential

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

COMPENSATION RANGE

The anticipated annual salary range for the Sr. QA Analyst is$100,000-$115,000. Salary determined based on relevant experience, skills and education.

The salary range for the Sr. QA Specialist position is $100,000-$115,000 annually. Does your compensation expectation fall within this range? Please provide any additional information you would like us to consider regarding your salary expectations.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning.
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities.
• Occasionally exposed to moving mechanical parts; caustic chemicals; hazardous waste.
• Occasionally exposed to loud noise levels
• Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required.

Movement

• Frequently required to stand; sit.
• Occasionally required to walk; climb or balance; and stoop/crouch.

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail

GENEZEN'S CURES VALUE-BASED COMPETENCIES

• Committed to Science
  We are committed toscientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
• Urgency in action for the patients
  We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
• Resilience & Grit in operations
  We are committed to overcoming challenges, learning from failures, and persistently striving for success.
• Execute with Excellence & Integrity
  We are dedicated to delivering quality results and upholding ethical principals.
• Solutions driven for our partners
  We are committed to being a proactive, collaborative, creative and open-minded partner.

GENEZEN'S BENEFITS

• Paid vacation days, amount based on tenure
• 401(k) plan with company match up to 6% of salary
• Choice of several healthcare plans
• FSA and HSA programs
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident insurance

ADDITIONAL DETAILS

• Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
• This position requires a criminal background check.
• Genezen is an Equal Opportunity Employer.
• Genezen participates in EVerify.
• Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.

Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.

Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 400, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.

Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.