QUALITY ASSURANCE SCIENTIST

QUALITY ASSURANCE SCIENTIST
Clinical Research Management, Inc. (?CRM?) is a government contractor specializing in infectious disease research in the US and abroad. CRM provides GxP services, research personnel, and support services, contributing to the development of vaccines, drugs, and devices, to help prevent, diagnose, and treat human disease. CRM has an immediate need for a Quality Assurance Scientist in Frederick, MD.



RESPONSIBILITIES
1. Compliance: USAMRMC computerized systems, electronic records and signatures compliance with the FDA requirements. The objective of this task is to execute oversight of electronic systems used to support IND studies. Audits of electronic systems used to conduct clinical studies to ensure compliance of all systems required to be in compliance with the 21CFR11 regulations. Compliance oversight of the validation of computerized systems used to support IND clinical studies to include review and approval of validation documentation such as IOPQ protocols, study reports and change control efforts activities.

2. Policy and Pamphlet Development: Identify, develop and staff Command policies for computerized systems and their validation. Support policies by writing pamphlets defining the minimum requirements for implementing the policies. The broad objective of this task is to define and implement best practices across the Command with regard to FDA-regulated activities computerized systems and electronic signatures compliance. Prior to implementing audits, criteria will be defined, set out in policies and checklists developed for implementation of policies and procedures.

3. Quality Plan: (1) In conjunction with the USAMMDA Regulatory Affairs support infrastructure such as SOPs and Quality Assurance processes necessary for computerized systems to be implemented at various sites and the timeline for implementation. Assist the sites who will be receiving the systems in the future with establishing their infrastructure (SOPs, equipment validation etc) so they are prepared when the MeRITS project is ready to bring their site on line. Develop and document an internal process that will assure continued compliance with DoD, Army, FDA and other Federal regulations after initial efforts. (2) Be able to identify trends, conduct root cause analysis of the problem and recommend solutions. (3) Identify, develop and staff internal QA SOPs for activities related to computerized systems, electronic records and electronic signatures. Such SOPs should include, but not be limited to audits and validation package reviews.

4. Command Resource: Serve as a resource for the Command with regard to FDA-regulated activities and compliance with 21CFR11 requirements. Follow up on study specific remediation efforts executed through the MeRITS project to ensure continued compliance. Serve as a subject matter expert to maintain the regulated electronic management systems in a compliant state. Assist with both formal and informal training opportunities.

5. Provide assistance to CRM Headquarters as needed on proposal writing projects and provide assistance with all job-related progress reports/technical reports.

6. Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.

7. Performs light duties and other related duties as required and assigned.




REQUIRED SKILLS / EXPERIENCE
1. Must have a Bachelors degree, although an advanced degree is a plus.

2. Must have a solid background with a minimum of 3 years experience in FDA regulated computerized systems, electronic records and electronic signatures.

3. Work must comply with standards established by Army Regulations, 21 CFR 11 and predicate FDA regulatory requirements for pharmaceuticals, biologics and devices.

4. Should have an understanding of product development, FDA compliance, and implementation of quality systems.

5. The candidate must be able to pass a National Agency Check.

6. Candidate must be a US Citizen or Permanent Resident.



ATTRIBUTES
CRM currently offers the following benefits to full-time employees:
? 3 weeks paid vacation, paid leave on federal holidays, paid sick leave
? Annual budget for tuition assistance, continuing education, seminars, etc.
? Health Insurance
? Long Term Disability Insurance
? 401(k) retirement plan with company matching
? Life Insurance
? Medical and Dependent Care Flexible Spending Accounts
? Other Benefits
Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, or national origin. Candidates for positions under CRM?s contracts with the Department of Defense (DOD) will be required to pass one or more background/security investigations conducted by the DOD, U.S. Army or other federal government agency. Such investigations may include criminal records and credit history checks.

CRM is an EOE.

* Please submit only 1 resume per position. Contact will only be made if there is further interest, based on qualifications.
* All posted opportunities are full-time position, unless otherwise stated.