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.
Quality Assurance Specialist II
Position Summary
In an inter-departmental team environment, works to facilitate/incorporate effective quality practices for new and existing clients. Acts as the Primary Quality Assurance Representative for designated clients. Review and approval of GMP Certificates of Analysis (CoA’s), deviations, and CAPAs. Reviews, as necessary manufacturing batch records in accordance with current Good Manufacturing Practices (cGMP), and Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies, as applicable. Monitor processes for adherence to established procedures/regulatory compliance
Essential Functions and Responsibilities
- Review and approve non-conforming events (NCE) and CAPAs.
- Pre-review/ approval of pre-executed batch records for assigned clients
- Post review of MFG batch records if required.
- Review / approval of MFG COA’s
- Perform timely review of complex study files, such as: Assay Validations, Process Validations
- 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 MFG 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 MFG 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), Points to Consider (PTC) guidelines and internal procedures in an efficient and timely manner. Assure that any observations/deviations are properly investigated and explained.
- Write and revise SOPs as necessary.
- Review and approve document change requests.
- Equipment Validation (IQ, OQ, PQ) and Change Control review/approval.
- 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 for on-site client visits. Participate/Lead to support internal and/or client audits
- Coordinate with Project teams in design, set up and execution of projects
- Review protocol and specifications for understanding and execution of orders.
- Facilitate and assure timely and accurate completion of pre and post executed batch records.
- Maybe required to work Holidays and weekends
- May be required to assist in other departments
- 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 Laboratory Practices and Good Manufacturing Practices
- Other duties as assigned
Knowledge, Skill & Ability
- Scientific, Laboratory, and/or Production experience required. Extensive experience is highly preferable.
- Knowledge of FDA GLP/ cGMP requirements, FDA PTC guidelines required.
- Knowledge of EU cGMPs highly desirable.
- Knowledge of FDA PTC & MHRA Out-of-Specification guidance documents required.
- Knowledge of Root Cause analysis techniques required.
- Extensive experience writing and/or reviewing/approving Laboratory Investigations / Deviations / CAPA’s preferable.
- Ability to accomplish the described duties through the use of appropriate computer equipment and software (Microsoft Word, Excel, 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
Education & Experience
- 4 years or more of relevant experience or equivalent
- BA/BS degree in a Science related major
Disclaimer
The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.
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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