QA Testing - Quality Assurance Compliance Specialist I

Minaris Advanced Therapies • Philadelphia, PA

71d • Onsite

About The Position

Be part of something bigger at Minaris Advanced Therapies—where every role contributes to creating hope for patients around the world. As a global leader in cell and gene therapy development, manufacturing, and testing, we turn breakthrough science into real-world treatments that change lives. Our team of over 1,000 experts across North America, Europe, and Asia has helped bring transformative therapies to market. At Minaris, you’ll join a purpose-driven community focused on innovation, collaboration, and patient impact. Whether you’re in the lab, in the cleanroom, or behind the scenes, your work will directly support life-saving therapies and make a lasting difference. If you're passionate about advancing cutting-edge science and believe in the potential of cell and gene therapies, we invite you to help shape the future of medicine—one patient at a time. Position Summary: Reviews laboratory testing data /records in accordance with current Good Manufacturing Practices (cGMP), and Good Laboratory Practices (GLP) as applicable. Monitor processes for adherence to established procedures/regulatory compliance. Provides guidance for quality related issues and consults with QA Management to resolve complex quality issues in a timely manner. Updates Standard Operating Procedure(s) and performs training. Is a backup for supervision/management

Requirements

• Ability to accomplish the duties described through the use of appropriate computer equipment and software (Microsoft Word, Excel, Outlook, and Access).
• Ability to accurately and reproducibly perform arithmetic, algebraic and geometric calculations.
• Ability to record data accurately and legibly.
• Ability to use judgment as dictated by the complexity of the situation.
• Ability to understand and follow verbal or demonstrated instructions.
• Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
• Ability to receive, comprehend and to effectively communicate detailed information through verbal and written communication.
• Proficient in Oral & Written communication skills.
• Need to be able to read, write and understand English.
• At least 2-5 years of relevant laboratory and/or QA experience or equivalent.
• Bachelors’ degree in a Science related field.

Responsibilities

• Compiles and reviews raw data and test results, including Final Reports and COAs, in accordance with cGMP, cGLP, Code of Federal Regulations (CFR) and internal procedures in an efficient and timely manner. Assure that any observations/deviations are properly investigated and explained.
• Performs timely review of complex study files, such as: Assay Validation and Qualifications.
• Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (e.g., ICH, ISPE, etc.).
• Reviews and approves document change requests.
• Perform QA inspections of Laboratories
• Participate/lead in Client audits.
• Perform timely review of Viral Clearance data.
• Perform review and approval of Laboratory Investigations (OOS) and Nonconforming events.
• Write nonconforming events or deviations if necessary.
• Write and revise SOPs as necessary.
• Perform trend analysis and report results for quality metrics.
• Assists Management in the training of new hires.
• Participate in quality and process improvement initiatives and project teams.
• Attend meetings as QA representative.
• Backup for QA supervision/management
• Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Normally receives minimal instructions on routine work and detailed instructions on new assignments.
• Ability to work in a team environment and independently as required.
• Regular and reliable attendance on a full-time basis.
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture.

Benefits

• Minaris Advanced Therapies employees are eligible for a comprehensive benefits package, including medical insurance, vision insurance, dental insurance, 401(k), paid time off, tuition assistance, and more.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 251-500 employees