Job description

SUMMARY

As a part of the Quality Assurance team, the Quality Assurance Specialist promotes and supports a culture of audit readiness within ACM Global Laboratories. Responsible for hosting customer audits & regulatory inspections, conducting internal audits, managing Quality Issue (QI) tracking, managing Corrective Actions & Preventive Actions (CAPA) and developing/ maintaining Standard Operating Procedures (SOPs).

STATUS: Full Time

LOCATION: 160 Elmgrove Park

DEPARTMENT: Quality Assurance

SCHEDULE: Days; Mon-Fri

ATTRIBUTES

• Bachelor’s degree preferred.
• 3 years of quality assurance experience required.
• Experience in a laboratory, pharmaceutical or Clinical Research Organization (CRO) preferred.
• Knowledge of and demonstrated experience in Good Clinical Practice (GCP), ISO15189, NEQAS, CAP, CLIA strongly preferred.

RESPONSIBILITIES

• Quality Assurance Independently perform a wide range of activities to support the Quality Assurance department by participating in the processes required to achieve & maintain the required accrediting agency/standards & regulatory requirements for the organization. Serve as Quality Assurance contact for assigned customers & functional areas (as required). Prepare for, carry out, report and follow-up of Quality Assurance required audits - including internal, 3rd party and vendor audits. Recommend systems for audit, write audit plans, coordinate scheduling & closure of internal audits. Monitor the compliance of all departments via routine audits to ensure adherence with internal Standard Operating Procedures & external regulations. Support the processes in place to ensure customer complaints are appropriately raised and handled. Provide oversight & participate in review root cause analysis, corrective action & preventive action plans for Quality Issues & customer complaints. Provide oversight to the documentation, reporting, effectiveness checks & closure of compliance issues (audits, Quality Issues & customer complaints).
• Process Improvement Support the promotion and compliance with regulations, guidelines, and Standard Operating Procedures within the organization. Provide input to the development of Quality Assurance Standard Operating Procedures & Processes, the Quality Manual and other organizational standard operating procedures & processes when required. Participate in review of root cause analysis, corrective action & preventive action plans for internal, 3rd party & vendor audits. Participate in Lean/Six Sigma process improvements. Support Quality Assurance related activities to ensure a harmonized quality management system.
• Training Serve as a resource promoting the development and understanding of the key elements related to Quality Management Systems & regulatory compliance requirements including training opportunities to staff at an organizational level. Participate in continuous professional development.

Rochester Regional Health System is an Equal Opportunity / Affirmative Action Employer. Minority/Female/Disability/Veteran.

PHYSICAL REQUIREMENTS:

S - Sedentary Work - Exerting up to 10 pounds of force occasionally Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

Any physical requirements reported by a prospective employee and/or employee’s physician or delegate will be considered for accommodations.

Rochester Regional Health is an Equal Opportunity/Affirmative Action Employer.
Minority/Female/Disability/Veterans by a prospective employee and/or employee’s Physician or delegate will be considered for accommodations.

Job Type: Full-time

Pay: $80,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: One location

jackharris.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, jackharris.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, jackharris.com is the ideal place to find your next job.