Proclinical is currently recruiting for a QA Document Control Specialist for a leading pharmaceutical company located in Sunnyvale, CA. Successful candidate with have experience in document control, Electronic Document Management System (EDMS), authoring SOPs, managing the archival of master documents, and working knowledge of Quality Systems, GMP and ICH guidelines.
Job Responsibilities:
- Process DCR packages and review for accuracy and completeness; manage in-process DCRs; create/generate moderately complex reports; issue and manage QA controlled lab notebooks and logbooks.
- Independently facilitate the Document Request process including providing formatting, coordinating the review and approval process, tracking and routing controlled documents.
- Perform administrative tasks to maintain the electronic document management system (EDMS), including collaborating with Document Control management to address/remediate process and EMDS issues and also support system updates/upgrades.
- Provide user assistance and training on document control and record management systems, processes, and procedures.
- Perform Document Control EDMS training for new employees.
- Perform duties in support of established records management procedures for paper and electronic records, including management of the on-site document vault and offsite records storage and retrieval.
- Manage and maintain the archival of master documents and records such that required documentation is retrievable and files are accurate, complete and well organized.
- Prepare document control metrics and reports.
- Provide support for audits and regulatory agency inspections.
- Manage/participate in projects/assignments that support continuous improvement efforts and department and goals as assigned by Quality Management.
- Represent Document Control in project and functional meetings.
- Provide general support for the overall Quality System.
- Initiate and revise applicable Document Control SOPs and Work Instructions, as required.
Skills and Requirements:
- 2-5 years of pharmaceutical experience in a GMP environment administering Document Control Systems.
- Bachelor's Degree or equivalent professional experience.
- Working knowledge of Quality Systems, GMP-related requirements and ICH guidelines, desirable.
- Working knowledge of electronic documentation systems, data retrieval, and electronic file formats.
- Detail oriented with solid problem-solving acumen.
- Ability to work effectively in a team environment.
- Ability to analyze and reconcile moderately complex issues.
- Must have demonstrated initiative and accountability in a fast-paced environment.
- Must demonstrate leadership skills through example.
- Excellent verbal and written communication and interpersonal skills.
- Proficient with computers and word processing software (i.e. Microsoft Office products).
To Apply:
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 Catherine Nguyen at (+1) 215-531-5643 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.
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