REMOTE QA GCP Auditor

A privately held Contract Research Organization (CRO) looking to hire a REMOTE QA GCP Auditor.

Under limited supervision, but following established policies and procedures, plan, schedule, conduct, report and close any type of GCP audits (e.g., eTMF, investigator site, database, vendor, process audits) on-site and/or remotely. Responsible for ensuring compliance with applicable Standard Operating Procedures (SOPs) and regulations by performing internal and external audits. Assists Department Head to promote Quality and Lead Process Improvements by preparing SOPs and other project/department specific procedures, providing training to staff, assist in maintaining quality management systems, conducting QA audits (Internal, Vendor, Site and TMF) and assist in hosting client audits when requested. Maintains records, creates reports, coordinates and schedules trainings. Responds to questions and/or provides information upon request from clients and internal staff.

MAJOR DUTIES AND RESPONSIBILITIES:

1. Audit Process Management

a. Conducts audits of vendors, investigator sites, company's internal processes, and Trial Master Files to assess compliance with applicable regulations/guidelines, customer requirements, Company's Clinical SOPs, and project specific guidelines/instructions.

b. Maintains QA Audit files;

c. Assist in hosting client audits or regulatory inspections as requested; Assists with management of audit/inspection logistics; Collects, reviews, manages audit/inspection related data and files;

d. Conducts internal audit activities; Collects, reviews, records and manages audit documentation

e. Distributes final audit reports to operations staff, management, and customers as per audit plans

f. May develop audit plans as required/requested.

g. Conducts audits of vendors, investigator sites, internal processes, and Trial Master Files to assess compliance with applicable regulations/guidelines, customer requirements, SOPs, and project specific guidelines/instructions.

h. Conducts joint audits for training, coaching, assessment, as needed.

i. Manages CAPA investigations as requested.

2. Training Process Management

a. Assists in the planning, scheduling, tracking and maintaining of database of all in-house trainings provided by QA.

b. Prepares agenda, schedules sessions, coordinates training materials and locations, generates training documents, distributes, and manages training document flow; collects training documents upon completion; ensures training documents are appropriately completed (including respective signatures and dates).

c. Assists as requested with providing New Employee/Orientation Training by providing QA overview as requested. d. Assists with other training activities as directed by the Vice President, RA/QA.

3. Utilizes tact and experience-based knowledge to resolve problems (clients or staff), explaining specific policies/regulations while representing the Company in a professional manner and maintain positive client relations.

4. Ensures adherence to SOPs, ICH Good Clinical Practice and FDA regulations.

5. Provides interpretation and consultation to project teams on regulations, guidelines, compliance status, policies and procedures.

6. Provides quality assurance consultancy activities and projects for clients, as directed, within budget and established timelines.

7. Performs other QA and/or administrative duties as assigned by the Vice President, RA/QA.

QUALIFICATIONS: Education: College degree in health care, a scientific field and/or in a field directly related to this position. QA Audit Certification is a plus. Minimum of 3 years QA experience of which at least 2 years are GCP auditing experience. GMP auditing experience is a plus. Three (3) years of directly related experience may be substituted for a college degree.

Experience/Skills/Knowledge:

1. Minimum 5 years of progressive pharmaceutical QA experience, preferably in a CRO or pharmaceutical company environment or a related area. Knowledgeable in commonly used concepts, practices and procedures within Clinical Trial GCP environment (additional GMP experience is a plus);

2. Demonstrates working knowledge of medical/scientific terminology and knowledge of FDA regulations/guidances and ICH GCP guidelines is required.

3. PC proficient including Microsoft Office (Word, Excel, Power Point, Outlook) and the Internet;

4. Excellent organizational, analytical, and problem-solving skills; Must possess an exceptional attention to detail and ability to produce quality and accurate work in required timeframes;

5. Ability to manage multiple projects/priorities simultaneously and produce the desired results;

6. Ability to work with highly confidential information, take initiative and exercise good judgment; some degree of creativity is needed;

7. Excellent verbal, written, telephone and interpersonal communications skills;

8. Ability to be flexible in dealing with changing priorities;

9. Ability to follow-through and react quickly to changing situations;

10. Demonstrated ability to anticipate risks and consequences of current issues on future project outcomes;

11. Must be a self-starter, capable of identifying needs/requirements;

12. Ability to work independently and in a team setting;

13. Ability to identify issues, recommend solutions and implement resolutions;

14. Ability to function in a business office environment and utilize standard office equipment including but not limited to: PC, scanner, fax, copier, telephone, etc.;

15. Travel required.