The QA Specialist role is key to our commitment to high quality and innovative growth. This position will focus on continual improvement and change management while also fulfilling fundamental QA roles. The QA Specialist will execute Quality System continual improvement initiatives stemming from customer audits, internal audits, CAPAs, and strategic planning exercises. These initiatives are intended to improved quality, efficiency, productivity and compliance. The QA Specialist will work closely and collaboratively with the Quality team, Laboratory and Leadership staff on improvement projects while actively contributing to positive co-worker/customer relationships.
- Lead the Corrective Action process in response to customer and internal audits and regulatory inspections, including but not limited to: design and execute Corrective Action project plans, drafting response reports, setting timelines and ensuring the completion of those actions on the communicated timelines.
- Design and implement actions in accordance to cGMPs and VR’s Quality System such as writing Change Control documentation, revising procedures, performing re-qualification/validation activities, etc.
- Monitor the execution of the Change Management process and ensure changes to validated/qualified systems are adequately risk assessed and return the system to a qualified state after the change.
- Write and review SOPs and other procedures related to the Quality System with the goal of collaborating with other stakeholders, and continually improving our processes for increased modernization, efficiency, compliance and to foster a continual improvement culture.
- Work with QA and Operations to close high risk compliance gaps to meet the goal of FDA inspection readiness.
- Evaluate processes for inefficiencies and opportunities to reduce non-value added tasks, increase user-friendliness, “engineer the human error out” and reduce the costs of poor quality.
- Facilitate efficiency improvements being driven by lab staff and others by reviewing proposals for compliance and congruence with the Quality System.
- Ensure ongoing proficiency in the applicable regulations and standards (21 CFR Parts 11, 210, 211, 820; ISO 17025) and aid VR Analytical’s continuing compliance.
- Monitor the timely completion of routine Quality System requirement tasks – support staff in completion, follow up on statuses, and provide updates to other QA and management staff.
- Become a subject matter expert in the EQMS platform user processes to 1) oversee the quality/compliance of the use and execution of processes in the system by users 2) help identify beneficial process improvements with the system; 3) train staff on the processes; and 4) continually support staff with questions & coaching related to the system.
- Responsible for improvement of the Training Program, conducting gap assessments, and working with staff toward improving training plan designs (i.e., Workstations, Onboarding, User Groups, etc.) for added value. May grow to include conducting Onboarding trainings of Quality System fundamentals.
- Assist the Head of Quality with changing needs, such as procedure improvements, customer and vendor Quality Agreements, Quality System Metrics, department strategic initiatives, etc.
- Monitor the execution of the Vendor Qualification Program including, but not limited to, the conduct of on-site audits of high risk vendors (e.g., laboratory subcontractors).
- Responsible for IT Coordinator duties, including being the on-site point person for the laboratory and office computer networks, the on-site point person for the contracted IT Service Company (e.g., Weston), overseeing and evaluating new software and hardware implementations proposals and projects, investigating technical issues when on-site investigation is needed, maintain computer and software logs, etc.
- Interact in a collaborative manner with other team members to contribute to positive co-worker relationships, and maintain a high degree of integrity in all aspects of QA and IT activities.
- 5+ years experience working with a regulated Quality System/GMP environment.
- Bachelor’s degree or higher in a related scientific field.
- Broad and detailed knowledge of GMP principles, practices and procedures, preferably in an analytical laboratory environment and with proficiency in data integrity principles.
- Highly proficient in Word, Excel, PowerPoint & Outlook.
- Proven ability to be a productive, efficient and positive team player.
- Experience working with innovative technology solutions.
- Experience with Computerized Systems/Spreadsheet Validation a plus.
- Passion for quality and continual improvement while maintaining positivity through challenges and imperfection.
- Must have a strong attention to detail and a demonstrated professional demeanor.
- Proven ability to effectively manage time while working on multiple assignments.
- Preferred: Analytical chemistry knowledge.
- Preferred: 2+ years using project management tools within project teams.
- Application must include a cover letter, resume, and three professional references, including your most recent employer and supervisor (we will not contact him/her until you give permission).
- Final candidate(s) education will be verified and will be required to pass a criminal background check.
- Due to the volume of applications received, we regret that we will not be able to contact every applicant. After screening applications, we will be in touch with those that meet our qualifications and requirement to schedule a phone interview.