QA Specialist II, Lab Operations

QA Specialist II, Lab Operations

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.

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

The Quality Assurance Specialist II – Laboratory Operations supports the day-to-day quality operations via oversight of all elements of the Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), investigations, excursions, change control, batch review and disposition, and data integrity in support of biologics manufacturing production with a focus on Quality Control activities. Additional responsibilities include providing supportive services to the Facilities Management (FM) and Manufacturing (MFG) groups including QA review of controlled documents related to product/utilities testing, and data review.

Essential Job Functions

• Review and approve data and records associated with in-process, drug substance (DS), drug product (DP), stability, clinical and commercial packaged product.
• Review and approve protocols, data, and reports relating to method validation, method transfer, and compendial testing.
• Review and approve protocols, data, and reports, in support or critical reagent qualification and requalification.
• Review and approve Environmental Monitoring Excursions and other laboratory investigations including subsequent Quality Investigations and Corrective and Preventive Actions (CAPAs).
• Provide metrics reporting and status updates to QA Management relating to laboratory QS activities.
• Create, review, and approve documents including Standard Operating Procedures and other documents, as needed.
• Provide daily QA support for general laboratory activities.
• Assist with internal and external audits as necessary (e.g. of CTLs)
• Represent Quality Assurance on project teams and in meetings.
• Support the continuous improvement and oversight of Quality Management System procedures.
• Perform other quality/compliance related tasks as required.

Special Job Requirements

• 2-6 years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment
• Well versed in cGMP/ICH/FDA/EU regulations and guidelines
• Proficient in using Microsoft applications (MS Word, MS Excel, MS Powerpoint)
• Experience in Quality Control preferred
• Adaptability required as work schedule may change based on business needs.
• Criminal background check required.
• Other duties as assigned

Knowledge, Skills and Experience

Physical Demands

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

Work Environment

• Regularly sit for long periods of time.

Movement

• Occasionally required to walk

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 to scientific 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 principles.

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
• Paid sick time
• 10 observed holidays + 2 floating holiday + 1 volunteer day
• 401(k) plan with company match up to 6% of salary, vested immediately
• Share Appreciation Rights
• Choice of several healthcare plans
• FSA and HSA programs
• Dental & vision care
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident insurance
• Accidental Death & Dismemberment (AD&D) 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 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 500, 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.