IT Quality and Compliance Specialist III
Proclinical is currently recruiting for an IT Quality and Compliance Specialist III with a biopharmaceutical company located in San Francisco, CA. Successful candidate will assist IT management in ensuring the activities of the IT group follow SOX and cGxP control requirements.
- Take a proactive posture to evolving procedures and practices to support new technology and change in business requirements.
- Contribute to and support the company's research and development efforts to create high value therapeutics to address unmet medical needs.
- Maintain multiple record types (logbooks, excel spreadsheets, physical documents, etc.) of all Change Requests (CRs), issuing new change request numbers to IT staff as requested.
- Review all CRs for compliance with applicable SOX, cGxP and IT quality requirements, routing only those CRs that meet those requirements.
- Ensure the Change Review Board (CRB) meets as required and all identified issues from the CRB are followed up on.
- Provide updates on the status of Open Change Requests to IT Management on a periodic basis.
- Support and perform IT Quality document control activities in order to ensure compliance within the controlled document management system both electronically and manually.
- Maintain multiple record types (excel spreadsheets, document lifecycle versions, as well as physical and electronic copies, etc.) of all IT Quality Documents (ITQDs) including, but not limited to i) IT quality system level documents, ii) IT arrangements, iii) access forms, and iv) IT system level passwords.
- Review all ITQDs for compliance with applicable SOX, cGxP and IT quality requirements, routing only those ITQDs that meet the requirements.
- Assist in gathering and generating the system access review and document access review reports/memos on a periodic basis.
- Provide guidance and assist IT staff to meet applicable ITQD requirements as time permits, and reviews and suggest revisions to ITQDs to help streamline IT operational efficiency.
Skills and Requirements:
- Bachelor's degree in a relevant discipline is preferred. Equivalent experience may be accepted. A minimum of 5 years work experience in a compliance or related role is required.
- Experience with systems like MasterControl, Veeva QualityDocs, ValGenesis and ServiceNow considered a plus.
- Must be a quick learner, team player, and possess outstanding organizational skills. Very good analytical and problem-solving skills are required.
- Strong skills in computer applications (MS Office, Word, Excel, Project) are required. Great interpersonal skills, with a focus on listening and questioning skills are required.
- Must possess excellent oral and written communication skills. Must be able to follow instructions and work well in a team environment.
- Experience in the Pharmaceutical, Biotech or Medical Product industry is preferred. Excellent customer service skills are required.
- Must have an excellent understanding of IT, SOX, and cGxP terminology and concepts.
- Some understanding of application processing and system development control techniques and related auditing techniques is preferred.
- Must be familiar with system design, computer operations, disaster recovery, data security and program change control. Familiarity with authentication and authorization architectures is preferred.
- Familiarity with internal controls as related to financial systems or FDA-related policies is preferred. Must have the ability to formulate and express ideas relating to difficult and highly technical concepts.
- Knowledge of project management methodologies is preferred.
- Previous experience with system implementations is preferred. Must possess good planning, decision making and judgement skills.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Ysabel Capitan at (+1) 347-293-1123 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.