Pharmaceutical - Document Control/Management, DocumentumPosted: November 11, 2009
Data Factory Translation Specialist
Location: Collegeville, PA 19426
Industry: Pharmaceutical
Interview Schedule: Phone screen, then personal interview with hiring manager and technical team leaders.
When reviewing this position, keep it mind it is titled Translation Specialist and is under the translation group. Translation of languages are done with 3rd party vendors, so while Spanish would be nice to have it is not required. The person who was previously doing this role was not bilingual.
Please review this opportunity and reply if you are interested. Please also forward this onto your friends, referrals, and network in order to help others out with the job search. The key skills are listed below:
Pharmaceutical background with Document Control and/or Document Management and/or Submissions
Focused individual with attention to detail, focus on deadlines.
Excellent MS WORD, EXCEL, PowerPoint Skills (creation of graphs and charts)
Excellent Multi Tasking ability
Electronic Document Management (EDMS)/Documentum experience preferred
Bilingual in Spanish & English Languages preferred; but, not required
Above average grammar & writing ability
Some technical with the ability to troubleshoot preferred
Customer focused with internal & external customers
Excellent organization skills
Ability to work under time constraints & meet time lines objectives
Cannot be a procrastinator & able to take direction
Ability to work w/minimal supervision
Exercise good judgment in decision making
Must be a team player with pleasant & outgoing personality
Familiar w/metric urgency (environment is heavily focused on metrics and productivity).
QA/QC experience preferred
Full job description is below.
There is no "cookie-cutter" background or experience that is a match for this position. The list above are the primary requirements of the position, with the full job description attached. This is an urgent need, and interviews will be scheduled quickly. Please reply or forward onto your contacts as soon as possible. Thanks you for the time.
Company Information:
Long history of pioneering developments in pharmaceuticals and biotechnology, with leading products in the areas of womens health care, neuroscience, musculoskeletal disorders, cardiovascular therapy, vaccines and infectious disease, hemophilia, immunology and oncology. A leader in the development of nutritionals.
Pay it forward, and forward this on!
If you have received this job description and are not interested, please forward the description and my contact information onto your network of contacts and friends. A lot of candidates learn of new job opportunities from word-of-mouth, and any referrals would be greatly appreciated. Our job opportunities are usually time sensitive, so please contact me immediately if interested. Thank you.
1. General Information:
Job Title: Data Factory Translation Specialist
Department: Regulatory Affairs - GPC Area:
Position Reports to: Translation Coordinator Position Supervises: N/A
2.
Job Purpose:
This position will be responsible for the Quality Control of all translated files received from the Translation Vendors. Reviews documentation to ensure completeness as required by the Global Product Conformance (GPC) Guidelines.
3.
Key Accountabilities:
Ensures translation documentation has been accurately translated.
Verifies all Affiliate re-work corrections have been incorporated and captured properly by the translation vendors and reports any discrepancies to the Translation Coordinator for corrective action.
Assists Translation Coordinator with Affiliate or Plant translation activities.
Assists in executing Data Factory translation processes in accordance with GPC Guidelines.
Prepares translation folders and imports files to be translated into folders.
Prepares translation columns in CMC Workbook.
Prepares and updates EDMS Verification Sheet for affiliate approval.
Attends weekly meetings with translation vendors to discuss translation issues.
Provides updates to Translation Coordinator and Data Factory Supervisors regarding translation issues.
Performs additional tasks to support GPC as designated by the Translation Coordinator or Data Factory Supervisor.
Job Knowledge / Technical Skills / Experience
A minimum of a degree level or equivalent qualifications
Experience in administrative work
Strong skills in English and Spanish languages (written and oral), preferred
Understanding of regulatory submission processes and Common Technical Document (CTD) structure preferred
Strong computer skills
Experience using Excel, WORD and Adobe Acrobat
Experience with EDMS, preferred
Understanding of Good Manufacturing Practices (GMP) guidelines
Interpersonal Skills
Attention to detail, right-first-time mentality
Ability to operate effectively in environment with routine tasks
Excellent organization and time management/task management
Strong desire to achieve optimal results with a strong "sense of urgency" to meet project deadlines
Ability to adapt and be flexible; multi-task
Good decision making ability
5. Job Breadth
Interaction with Data Factory members, Translation Coordinator, Data Factory Supervisors, Regional Data Factory Lead and Regional Hub Lead
Interaction with different departments within the Plant, Affiliate, and Regional Hub including Regulatory Affairs & Regulatory Conformance
Interaction with the translation vendor
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