Senior Specialist, Quality & Regulatory - IUVO BIOSCIENCE OPERATIONS, LLC

iuvo BioScience is a Premier Partner Research Organization serving the Medical Device, Pharmaceutical, and Ophthalmic industries. We provide strategic guidance and testing services – from research to release - leveraging our preclinical testing, CMC/technical services, and clinical research experience to deliver exquisite science, develop valuable insights, and author flawless documentation. We do it all with a commitment to exceptional service.

 We offer a comprehensive benefits package (medical/dental/vision/401k/PTO) and the opportunity to broaden your experience working with top level medical device and pharmaceutical clients to improve the quality of life for patients and consumers around the world.

We currently have an opening for a Senior Specialist to join our Quality & Regulatory team.  

SUMMARY

The Senior Specialist, Quality & Regulatory, is primarily responsible for the review and release of GLP and GMP study data and reports for the testing departments, conducting GLP study audits, the review and approval of quality event documents (investigations, deviations, audit responses, customer complaints, CAPAs), quality records management (including archiving and management of on-site and off-site records storage) and providing assistance in the management of quality system activities. The Senior Specialist is responsible for tracking performance to ensure timely and successful completion of annual validation plan.  With the Sr. Manager, Quality & Regulatory, the Senior Specialist ensures the Quality System is robust and in compliance with regulatory and notified body expectations. They assist in hosting routine customer, as well as regulatory agency and notified body, inspections and conducting internal and supplier audits.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Develop, publish, and track to completion the annual Validation Master Plan in conjunction with Lab Operations and Sr. Manager, Quality & Regulatory
• Review and approve Validation documents
• Perform routine management of external standards
• Review GLP and GMP study data and reports for the testing departments
• Conduct GLP study audits
• Assist Sr. Manager to host customer, regulatory and notified body inspections
• Assist with Quality System Training (QSR, ISO, GMP and GLP)
• Assist with supplier and internal audits
• Assist in the management of quality system activities
• Write / approve work instructions

      Additional Quality System Responsibilities:

• Organizational Processes:
  • Management of deviations, investigations (e.g. Corrective & Preventive Action (CAPA) Reports)
  • Document change controls (SOPs, Forms)
  • Archiving and records management
  • Equipment/Process Change Control
  • Participate in quality improvement projects
  • All other tasks as assigned by department management.

QUALIFICATIONS & REQUIREMENTS

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.

EDUCATION and/or EXPERIENCE

Minimum BS or AAS in the biological sciences or related field with minimum 4 years of Quality Assurance or other relevant experience.  Experience in the medical device and / or pharmaceutical industry preferred, knowledge of ISO, GLPs and GMPs/QSR strongly recommended.

COMPUTER SKILLS

Proficiency with Microsoft Office (Word, Excel), experience with electronic quality management system a plus.

COMMUNICATION SKILLS

Expert ability to read and interpret documents and reports.  Must have excellent proofreading, spelling, grammar and writing skills.  Must have the ability to speak effectively before senior management, Regulators, groups of customers and employees of the organization.  Must have well-developed interpersonal communication skills.

MATHEMATICAL SKILLS

Ability to perform the calculations used in manipulating routine laboratory data.

OTHER SKILLS and ABILITIES

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.  Must be able to schedule tasks, organize time and plan ahead. 

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to sit, stand, and walk, use hands to manipulate objects or controls, reach with hands and arms, talk, and hear.

The employee may occasionally lift and/or move up to 30 pounds. 

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Combination of office and laboratory settings (with typical laboratory risks)  where moderate noise levels may exist.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

LOCATION Rush, New York

TRAVEL None

DISCLAIMER

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

iuvo BioScience is an Equal Opportunity Employer