New

Documentation Specialist

Spectraforce Technologies

Jan 09, 2025
Job Title: Documentation Specialist Duration: 03 months (high possibility of extension) Location: Branchburg NJ Shift Schedule: Work schedule will be anywhere between 6am- 6pm M-F Job Duties Responsible for quality of assigned products which may include small molecule pharmaceuticals and/or biologics products, combination products, and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates or Drug Products produced by plants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. Develops in concert with Regulatory Affairs, the appropriate regulatory strategies for product brands. Grade is commensurate on level of overall responsibility. This position is responsible for managing all Branchburg Quality Records, such as production donor, batch, and medical device records. Working with other departmental personnel, the Documentation Coordinator will maintain and file records, as well as maintain the file room. This position will prepare, process, and sustain storage of in-house and offsite records, as well as support the creation of electronic files of records. The Documentation Coordinator will interact with other departments, including Production, Tissue Services and Quality Control, to complete request orders of files, charts and documents. Education and Experience * High School Diploma. * At least one year of experience in an office environment (filing, scanning, etc.) * Excellent knowledge of MS Office applications including : Word, Excel, SharePoint, Outlook etc. ESSENTIAL SKILLS: Refer to the role detail (or similar role details), located on My Career, to determine the appropriate Leadership and Professional skills. * Previous experience working in a documentation/records management environment. * Skill in data entry performance and record maintenance * Knowledge of electronic and paper record archiving methods. * Administrative skills, able to pull charts, files and documents for all requests in a timely manner. * Ability to establish and maintain effective working relationships with other departments. * Handles patient, customer and company confidential information with tact and discretion. * Well organized with the ability to pay attention to detail. * Superior ability to foster and sustain professional relationships with all coworkers and clients * High adaptability to changes in work pace and volume * Outstanding oral and written communication abilities * Ability to lift approximately 35 pounds while archiving documentation. Position will also require long periods of standing, sitting, bending, and lifting..