QA Compliance - Quality Assurance Specialist III

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

As part of an inter-departmental team environment, works to facilitate/incorporate effective quality practices for new and existing clients. Acts as Primary Quality Assurance Representative for major clients Review and approve Certificates of Analysis (CoA’s), deviations, and CAPAs. Reviews, as necessary, manufacturing batch records in accordance with current Good Manufacturing Practices (cGMP).

Essential Functions And Responsibilities

• Conducts the review of Manufacturing batch records in accordance to cGMP, GLP, and internal procedures in an efficient and timely manner.
• Assure that investigations/deviations are properly investigated and explained.
• Post review of MFG batch records if required.
• Review/approval of MFG COA’s, Product specifications, label specifications
• 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 and determine if issues can be addressed with batch record comments or require escalation.
• 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.
• Work with document reviewers to review raw data, batch records and test results in an efficient and timely manner.
• Assure that any observations/deviations are properly investigated and explained.
• Write, review and revise SOPs as necessary.
• Participate/Lead internal and client audits, supplier audits, regulatory inspections
• Review and approve Change Controls, Document Change Requests and Technical Transfers
• Equipment Validation (IQ, OQ, PQ) and Change Control review/approval as required
• Participate in quality and process improvement initiatives and project teams.
• QA contact for on-site client visits
• Coordinate with Project teams in design, set up and execution of projects
• Review protocol and specifications for understanding and execution of orders
• 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
• May be required to assist in other departments
  
  

Knowledge, Skills & Ability

• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
• Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
• Networks with key contacts outside own area of expertise
• Determines methods and procedures on new assignments and may coordinate activities of other personnel (QA Team Lead).
• Knowledge of FDA and EU cGMP requirements
• Knowledge of Root Cause analysis techniques required.
• Extensive experience writing and/or reviewing/approving Investigations / Deviations / CAPA’s preferable.
• Ability to use judgment as dictated by the complexity of the situation.
• Ability to work effectively as part of a team and to exhibit excellent interpersonal skills.
• Ability to receive, comprehend and to effectively communicate detailed information through verbal and written communication
• Knowledge of GLP and cGMP requirements, PTC guidelines and ISO17205 is highly desirable.
• 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
  
  

Education & Experience

• 8 years of relevant experience or equivalent
• Bachelors’ degree in a Science related field or equivalent experience
  
  

Physical Requirements

• 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
• Ability to stand /Sit/walk for long periods of time
  
  

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.