A leading US biopharmaceutical organisation with a solid commercial portfolio of life-saving drugs within many therapy areas have a new Quality Docs and Training Admin job opportunity at their offices in Foster City, CA. The company has a growing pipeline of investigational drugs and approximately 5,000 employees in offices across four continents.
- This position supports the global Quality Documents and Training Administration (QDTA) function within Regulatory Compliance Department.
- This position supports the day-to-day document control activities for North and South America and Asia Pacific. Duties include but not limited to, assisting with internal customers, and administrative support of the document management system.
- As needed, this position works closely QDTA colleagues in Foster City CA, and in the United Kingdom to assure worldwide compliance requirements and customer needs are addressed promptly and with high quality.
- Participation on projects teams and on special assignments, as designated.
- Provides support in internal audits and in regulatory agency inspections.
- Evaluating and processing document change requests.
- Providing guidance and support to departments on word processing issues such as creation of protected forms.
- Providing final processing, incl. formatting, of procedural documents, and assured consistency of terminology and format across all procedures.
- Assisting with the periodic procedural document review process and tracking change requests resulting from the reviews.
- Supporting the approval routing and maintenance of other controlled document types in the document management system.
- Providing customer support and training on the use of the document management system.
- Working with customers as needed to assure procedures are written in accordance with standard authoring practices.
- May support archiving of records, including data entry in the electronic index, preparing records for onsite and offsite archiving, and filing.
- May support continuous improvement efforts to drive customer satisfaction, compliance, and business efficiencies, such as:
- Contributing to the implementation, deployment, and ongoing maintenance of new technology solutions.
- Creating metrics and administrative reports on a monthly and as needed basis.
- Participating in the creation or revision of procedural documents related to the control of quality records and procedural documents.
- As needed, supports training administrative activities on an ad hoc basis, including, but not limited to, management of training-related documentation, and quality control of data entry.
- Providing support during internal audits and regulatory agency inspections. Retrieves and provides documents as needed. May support other "backroom"-specific activities during an inspection
Skills and Requirements:
- Experience with use of document management system software and applications.
- Experience working in a GxP setting desired.
- Familiarity with document management practices.
- Must be able to operate both as an individual contributor and as a dependable, collaborative team member.
- Must be customer oriented but understand the compliance-driven nature of the position.
- Must be proficient with Microsoft Word (advanced skills preferred) and Excel.
- Must have demonstrated ability and willingness to conduct routine work, such as data entry, while displaying flexibility and independence in spotting or anticipating and resolving problems.
- Must have excellent attention to detail and ability to consistently meet high standards of quality required in compliance.
- Must have good oral and written communication skills, as well as effective interpersonal skills; is able to work efficiently with customers and colleagues across geographical locations
- Must possess good organizational and time management 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 Hannah Cihlar on +1 267 983 0133 or upload your CV 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.