Quality Assurance Manufacturing Specialist I

Minaris Advanced Therapies-posted 6 days ago

Full-time • Entry Level

Philadelphia, PA

251-500 employees

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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 Specialist role to provide Quality oversight in manufacturing operations at the site and monitor processes for adherence to established procedures/regulatory compliance. As part of an inter-departmental team environment, collaborate with subject matter experts to resolve any Quality issues or improvements for new and existing clients, including being the QA single point of contacts for clients. Review and approve manufacturing batch records, non-conformances, deviations, and CAPAs in accordance with cGMP. Prepare Certificate of Analysis for batch release.

Review and approve low-risk non-conforming events (NCE), deviation and CAPA.
Review and approve pre-executed batch records for assigned clients
Review and approve executed Manufacturing batch records.
Prepare Manufacturing release checklist and COA’s
Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (ie: ICH, ISPE, etc.).
Interact with Manufacturing management to provide quality perspective on routine operations and support systems. Address conditions/practices with appropriate personnel, documents and reports findings to Management.
Interact with project team to assure that project requirements and details are understood and effectively translated into MFG records.
Interact with QA batch record reviewers to communicate project requirements and assure that details are adequately translated into Manufacturing records.
Work with document reviewers to compile and review raw data, batch records and test results, including Final Reports and CoA’s, in accordance with cGMP, Code of Federal Regulations (CFR) and internal procedures in an efficient and timely manner. Assure that any observations/deviations are properly investigated and explained.
Revise SOPs as necessary.
Review and approve document change requests.
Participate in quality and process improvement initiatives and project teams.
Coordinate execution of Manufacturing Suite inspections.
Participate as needed to support internal audits, client audits, supplier audits, regulatory inspections.
Contact clients for on-site visits.
Maybe required to work Holidays and weekends
Contributes to the overall operations and to the achievement of departmental goals
Perform job specific tasks in compliance with applicable Regulations, International Standards, and Minaris Advanced Therapies Policies and Standard Operating Procedures.
Thorough understanding of Good Manufacturing Practices
Other duties as assigned
Potential to be selected for Visual Inspection Qualification. Selected individuals are required to inspect final product in a light booth to detect defects and record the pass/fail results of their inspection

Knowledge of cGMP requirements
Knowledge of Root Cause analysis techniques required.
Extensive experience writing and/or reviewing/approving Laboratory Investigations / Deviations / CAPA’s preferable.
Ability to accomplish the duties described through the use of appropriate computer equipment and software (Microsoft Word, Excel, and Access).
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.
3 - 5 years or more of relevant experience or equivalent
Bachelor’s degree in a Science or equivalent experience
Must be able to work in an office environment with minimal noise conditions.
Must be able to work in Lab setting with Biohazards /various Chemicals
Must be able to wear appropriate PPE
Must be able to work in environment with variable noise levels
Ability to stand /Sit/walk for long periods of time
Clarity of Vision
Ability to identify and distinguish colors
Must be able to perform activities with repetitive motions
Ability to climb Ladders / Stairs / Scaffolding
Ability to work in variable temperatures high to freezing
Inside/outside working conditions
If selected to become qualified for visual inspection, the employee must pass an eye exam including corrected or uncorrected 20/20 vision, ability to pass a color blindness test, and ability to pass a depth perception test

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.

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