Senior QA Auditor
Client Auditing Key Responsibilities:
- Act as the Project Coordinator of for audits including contacting sites, scheduling, and responding to client requests
- Audit Responsibilities include:
- GLP, GCP, GMP Audits
- Audit preparation and agenda
- Audit conduct (on-site and remote)
- Audit reports.
- Review of CAPA action plans
- Initial, Routine, and For cause Audits
- Report all project details to the Director of Quality Services (document status, document delivery, scheduling)
- This position may include supplier management, supplier risk assessments, training, and other auditing related responsibilities.
Note that this position is expected to have 60-70% travel including conducting a minimum of three on-site audits a month. Remote work is expected for audit preparation and reporting, and virtual audits.
Serve as a Quality Management System Subject Matter Expert
Support efforts to maintain Documents on Demand Catalog by reviewing procedures, forms and templates.
Consulting Quality Unit Responsbility:
- Write procedures for Consulting QMS, as needed.
- Assist with Azzur Group Consulting Training on Consulting QMS
- Manage Subject Matter Experts and review documents
- Bachelor’s Degree
- Bachelor’s Degree with a study concentration in a scientific discipline, preferably the biopharma/med device industry.
Required Work Experience:
- Quality Systems in Pharmaceutical, Biopharmaceutical and/or Medical Device
- 3 yr experience as a lead auditor
- GLP and GMP Manufacturing experience in the Pharmaceutical and/or Medical Device industry
- 6 yrs or more experience as a technical contributor and/or as a lead auditor
- Customer service experience is highly preferred
- Experience with accounting, financing and related activities
- GCP Clinical Site and CRO Auditing Experience
- GTP and gene therapy experience
- Microsoft office
- Knowledge of Regulations and Standards related to auditing
- Knowledge of Smartsheet
Skills (incl.Typical Mental Demands):
Reasoning Ability/Mathematical Skills/Computer Skills/Language Skills:
- Computer skills, basic mathematical skills, use of spreadsheets
· Customer service/client relations
· Communication proficiency
· Attention to detail
· Can work productively independently with minor supervision
· Self-motivated, flexible, dependable and available
· Excellent organizational and time management skills
· Excellent word processing and computerized system skills
QA Auditor to perform Pharmaceutical, Biopharmaceutical, and Medical Device GLP, GCP and GMP supplier, internal, and for-cause audits for clients. The Auditor is expected to have previous experience as a lead auditor and to have at least three on-site audits/month so travel can be 60-70% time. Preference is for an auditor who is located in the North East US. Audits are typically 1-3 days, and the rest of the time work such as audit preparation and reports can be remote.
Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.