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 TrackWise, Veeva and Minitab.
• Excellent English communication skills, both oral and written, and comprehension are required. Ability to effectively present information to top management, employees, or customers.

Physical Environment and Requirements

• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.

Expected Salary range:
$79,900-$85,000
The salary range displayed is the minimum and maximum salary range for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.
American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

American Regent Inc. endeavors to make
https://careers.americanregent.com/
accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email
hrtalentacquisition@americanregent.com

• 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