Quality Specialist 3

About the role

As the Quality Assurance Specialist 3, you will perform a variety of tasks within the Quality Assurance department including conducting audits and review/approval of various types of regulated documentation.

Responsibilities

• Review and approve standard operating procedures (SOPs), laboratory/batch records, GMP part numbers, and other quality records.
• Review and approve study files against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports, cell banking production records, and certificates of analysis.
• Review and approve deviations/OOS records of varying impact and criticality.
• Conduct trend analysis for deviations and review/approve applicable CAPA records.
• Conduct laboratory inspections to include commissioning and/or internal audits.
• Provide support for regulatory inspections.
• Lead and/or participate in projects as QA subject matter expert and drive discussions to build consensus across the business regarding Quality topics.

Requirements

• Bachelor's Degree in Biology, Chemistry, Engineering, or other scientific field with 4+ years' experience in Quality Assurance within a GxP environment.

Qualifications

• Experience reviewing batch records, event records, CAPAs and GCCs.
• Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity).
• Excellent communication and interpersonal skills.
• Acts ethically and ensures quality of own work and that of others.
• Open-minded, flexible and works with agility.
• Takes responsibility for ensuring that turnaround times are met.
• Works with cross-functional teams and builds networks within QA and Operations departments.
• Collaborates with various teams to identify and implement improvements.
• Willing to embrace and implement change on a global scale.

Pay

Pay range for this position is $70,800 - $106,200. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses.

Benefits

• Health insurance
• Paid time off (PTO)
• Retirement contributions
• Other perquisites

About Us

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!