QA Specialist - Deviations

** Nature and Scope
** The QA Specialist - Deviations will be responsible for effectively ensuring non-routine events are investigated and documented in accordance with company SOPs, policies and cGMPs.  This is a cross-functional position that interacts with all departments at American Regent.  Ensures quality system compliance with GMPs, procedures and documentation within the company and in keeping with regulatory requirements and company procedures. The role is responsible for authoring, reviewing, and providing the final Quality approval for investigations into manufacturing and laboratory events/deviations.

The role interacts with all levels of the organization and is expected to use professional judgment in appropriate issue escalation to management.
** Essential Duties and Responsibilities
** Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
* Ensures any non-routine events associated with the manufacture of safe, pure, and effective sterile pharmaceuticals are investigated and documented in accordance with company SOPs, policies and cGMPs and within assigned timelines. Identify trends, evaluate metrics, and provide support for internal audits under the direction of the QA Deviations Supervisor.  + Ensure deviation timelines are maintained through inter-department communication.  + Facilitate and lead assigned investigations involving multiple investigation areas.  

+ Facilitate and participate in initiatives to address compliance gaps identified during investigations with minimal assistance. Provide quality system level assessments and reviews, author and facilitate change requests.
* Initiate and complete or assign investigations and CAPAs related to Quality departments (Quality Operations, Quality Control, Quality Systems).
* Perform and guide root-cause analysis for events utilizing investigation tools (e.g., 5 whys, 6M, Fishbone Diagrams).
* Perform the QA review and final approval signature for assigned deviations/events, confirming the completeness, accuracy, and consistency of all work so that it meets the standards of quality. Identify errors and inconsistencies and initiate resolution to ensure high quality.
* Coordinate/provide oversight for the investigations system, including follow up with cross-functional stakeholders (assignees, internal customers, reviewers, and approvers). Act as a liaison between Operations and Quality in all matters related to investigations and CAPA.
* Under supervision assist with documentation for the closure of complaint investigations.
* Gather data for reports, metrics, Annual Product reviews and external requests. Generate and analyze metrics as assigned, employing statistical techniques as appropriate.
* Scheduling departmental meetings, maintaining meeting minutes and attendance.
* Maintain departmental records and files (both electronic and manual).
* Participate in cross-functional project teams as required.
* Support, coordinate, and assist with regulatory agency audits and inspections as required.
* Support and maintain quality programs, policies, processes, procedures, and controls ensuring compliance with current Good Manufacturing Practices (cGMP).
* Keep training curriculum current in ISO train.
* Ensure all work is performed and documented in accordance with existing company policies and procedures.
* Perform any other tasks/duties as assigned by management.
** Education Requirements and Qualifications
** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
* Bachelor’s degree in a science or engineering field, or in lieu of a bachelor’s degree, 8 years’ experience in QA/QC in regulated environment, required.
* ASQ Certification as a Quality Engineer or Six Sigma Black belt preferred.
* Minimum of 2-5 years of experience working in a Quality role within a cGMP manufacturing environment required.
* Knowledge and understanding of quality assurance principles, controls, and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc.
* Strong attention to detail, adherence to SOPs.
* Ability to work effectively in a collaborative environment.
* Ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results.
* Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues.
* Ability to apply critical thinking to scientific problems and demonstrated knowledge.
* Ability to apply statistical quality management concepts.
* PC Skills Required (MS Word, Excel). Preference will be given to candidates with demonstrated knowledge of Quality software such as Track Wise, Veeva and Minitab.
* Excellent English communication skills, both oral and written, and…