This QA/Documemt Control Temp position will support the regulatory/quality team.
- Review/edit marketing collateral materials/labeling ensuring compliance to regulatory/procedural requirements
- Coordinate/facilitate cross functional meetings for marketing materials reviews
- Experienced working with document change control processes in a regulated environment
- Work with electronic document management systems – having MasterControl experience a plus
- Review QA documentation for accuracy, completeness and proper documentation practices
- Experienced with operating in a regulated environment (pharma, medical device, clinical lab, etc.)
- Working knowledge of quality and regulatory standards such as CLIA, FDA QSR and ISO 13485
- High proficiency with MS applications (PowerPoint, Excel, Word)
- Ability to multi task and operate with minimal supervision
- Highly organized and detail oriented
- Strong interpersonal and communications skills
- Ideally have worked in regulated environment (pharma, medical device, clin lab) for 5 yrs+
- Strong collaboration and interpersonal skills
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is frequently required to sit; talk; or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop; kneel; or crouch The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision and depth perception.