Quality Assurance Specialist III - TestingMinaris Advanced Therapies • United States
This job offer is no longer available
Quality Assurance Specialist III - Testing
Minaris Advanced Therapies
- United States
- United States
About
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
Primary Quality Assurance Representative for review of GLP Final Reports, GMP, Certificates of Analysis (CoA's), Assay Validations, deviations, and CAPAs. Reviews laboratory testing data or 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. Provides guidance for quality related issues and consults with QA Management to resolve complex quality issues in a timely manner.
Essential Functions and Responsibilities
Focused QA Representative on review/approval of Non-Conforming Events (NCEs), Deviations, Laboratory Investigations (OOS), and CAPAs; will coach/mentor Laboratory personnel in development of technical writing skills. Ensures site adherence to Quality Systems. Perform timely review of complex study files, such as: Assay Validations, Process Validations, and Viral Clearance. Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (i.e.,: ICH, ISPE, etc.). Maintains awareness of activities by routine direct observation of testing laboratories and manufacturing suites. Interact frequently with operations/facility staff to provide quality perspective on routine operations and support systems. Address conditions/practices with appropriate personnel, documents and reports findings to Management. Compiles and reviews raw data / laboratory test results, including Final Reports and CoA's, in accordance with cGMP, cGLP, 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. Reviews and approves document change requests. Perform QA inspections including, but not limited to GLP studies. Participate in quality and process improvement initiatives, and project teams. Performs Laboratory and Manufacturing Suite inspections. Participate as needed to support internal audits, client audits, supplier audits, regulatory inspections. 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. 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 Advance 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 Leadership Responsibility
Supports a diverse and inclusive culture and workforce, ensures compliance with laws, regulations, and company policies. Identifies, recruits, and retains top-notch talent. Sets performance standards and encourages employee engagement through delegation, continuous feedback, goal setting and performance management. Develop employees to meet both their career and organizational goals. Builds strong customer relationships and delivers customer-centric solutions. Maintains transparent communication, appropriately communicates organizational information through department meetings, one-on-one meetings, email, and regular interpersonal communication. Comfortable working in ambiguous situations and adaptable to change. Must model the highest degree of moral and ethical behavior and maintain confidential information. High degree of autonomy and strong decision-making skills. Knowledge, Skills & 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 Ability to accomplish the described duties 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
7 or more years of experience Bachelors' degree in a Science related field or equivalent experience Quality Requirements
Ensure compliance with all FDA and Worldwide Quality & Compliance regulations in all aspects of your work. Adhere to established procedures and protocols, prioritize continuous training and skill development, and uphold the highest standards of data integrity to ensure accuracy, compliance, and operational excellence. Physical Requirements
Must be able to work in an office environment with minimal noise conditions. Must be able to wear appropriate PPE Ability to stand /Sit/walk for long periods of time Must be able to work in Lab setting with Biohazards /various Chemicals Must be able to work in environment with variable noise levels Ability to Lift 10 lbs routinely Ability to crouch, bend, twist, and reach Ability to push/pull 10 lbs routinely/ often / occasionally 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
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.
Languages
- English
Notice for Users
This job was posted by one of our partners. You can view the original job source here.