Job Description
This is an onsite position 100%.
Job SUMMARY:
Supervise the development, creation, and revision of controlled documentation in accordance with the client s policies and procedures, current GMP, 21CFR820, ISO 13485 and AATB Standards. Establish partnerships with Managers and supervisors throughout local and global functions. Work with Change Control, Quality Investigations /CAPA team members, and other cross functional managers/supervisors and development engineers/teams to ensure that controlled documents being revised contain the correct information/parameters per process/product specifications. Serves as a primary contact for change initiators and provides guidance on the process as required. Evaluates and resolves quality issues with minimal supervision. Serves as a representative for Quality Documentation and Change Control during regulatory audits. Fulfill the responsibilities and tasks of the Change Control Manager in their absence as well as be a team lead and provide guidance and direction to other team members.
Top 3 5 Skills Needed for each role
1. Technical Writing
2. Change Management
3. Records Management
KEY DUTIES AND RESPONSIBILITIES:
Job SUMMARY:
Supervise the development, creation, and revision of controlled documentation in accordance with the client s policies and procedures, current GMP, 21CFR820, ISO 13485 and AATB Standards. Establish partnerships with Managers and supervisors throughout local and global functions. Work with Change Control, Quality Investigations /CAPA team members, and other cross functional managers/supervisors and development engineers/teams to ensure that controlled documents being revised contain the correct information/parameters per process/product specifications. Serves as a primary contact for change initiators and provides guidance on the process as required. Evaluates and resolves quality issues with minimal supervision. Serves as a representative for Quality Documentation and Change Control during regulatory audits. Fulfill the responsibilities and tasks of the Change Control Manager in their absence as well as be a team lead and provide guidance and direction to other team members.
Top 3 5 Skills Needed for each role
1. Technical Writing
2. Change Management
3. Records Management
KEY DUTIES AND RESPONSIBILITIES:
- Author changes to controlled documentation, including but not limited to standard operating procedures, work instructions, batch records and forms. -25%
- Act as Initiator for Change Controls. Work with complex tasks and tight deadlines. Responsible for the execution of all steps to ensure timely completion of changes. -15%
- Act as subject matter expert in document creation, format and alteration as well as EDMS use. Gathers information from SMEs, breaks complex processes into straightforward steps and ensures that procedures/documents contain the appropriate level of detail and instruction commensurate with the activity. -10%
- Active member in cross-functional collaborative efforts, attends huddles, team meetings. Participates in project team meetings, working collaboratively with project team members from Manufacturing, Engineering, Process Development, Quality, and other subject-matter experts to develop document content.
- Supports 5S methodology and ensures the area is safe and pleasant working environment. -10%
- Processes controlled documentation in the EDMS (Electronic Documentation Management System) in accordance with policies and procedures. -10%
- Reviews and evaluates change requests of varying complexity with minimal supervision. 5%
- Evaluates objective data associated with various change requests and follows up on activities required for closure. -5%
- Collaborate with internal and external customers. -5%
- Develop and implement process improvements regarding electronic document management system methods and provide training to support staff accordingly. -5%
- Represent Documentation and Change Control during regulatory audits-5%
- Communicates with management on a routine basis and escalates issues as needed. -5%
- Bachelor s degree, or 5-7 years equivalent experience.
- 3-5 years experience in a technical writing position within a pharmaceutical, medical device or biotech company.
- In-depth knowledge of MS Word including use of tables, headers/footers, and review capabilities.
- In-depth knowledge of EDMS (One Vault) and ERP System (SAP).
- Project Management capabilities.
- Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
- In depth knowledge of document authoring tools, including MS Office Suite.
- Demonstrated ability in proofreading and editing.
- Ability to multi-task and adjust to shifting priorities.
- Strong interpersonal skills including the ability to effectively work and actively communicate with people and cross-functional teams.
- Excellent oral and written communication skills as well as strong organizational skills.
- Strong analytical skills, with an eagerness to work hard and achieve exemplary results.
- Expert grammatical competency and writing skills.
- Basic knowledge of FDA, GXP, 21CFR820, ISO 13485 and AATB requirements and industry best practices.
- Able to work professionally and courteously within a team environment sharing roles and responsibilities.
- Ability to provide training and guidance to initiators of change requests.
Numbers & Facts
| Location | Branchburg, NJ |
| Industry | Staffing/Employment Agencies |
| Company Size | 10 to 19 employees |
| Website | http://www.colcon.com |
About Company
Skills
- Alliance/Partner Managementunmatched
- Analysis Skillsunmatched
- Best Practicesunmatched
- Biotech and Pharmaceuticalunmatched
- Change Controlunmatched
- Change Managementunmatched
- Change Requests/Ordersunmatched
- Code of Federal Regulationsunmatched
- Communication Skillsunmatched
- Content Developmentunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Cross-Functionalunmatched
- Data Collectionunmatched
- Document Managementunmatched
- Documentationunmatched
- Documentation Formatunmatched
- ERP (Enterprise Resource Planning)unmatched
- Establish Prioritiesunmatched
- FDA (Food and Drug Administration)unmatched
- GMP (Good Manufacturing Practices)unmatched
- GxPunmatched
- ISO (International Organization for Standardization)unmatched
- Interpersonal Skillsunmatched
- Manufacturingunmatched
- Medical Equipmentunmatched
- Microsoft Officeunmatched
- Microsoft Wordunmatched
- Multitaskingunmatched
- Organizational Skillsunmatched
- People Managementunmatched
- Presentation/Verbal Skillsunmatched
- Problem Solving Skillsunmatched
- Process Control Engineeringunmatched
- Process Developmentunmatched
- Process Improvementunmatched
- Project/Program Managementunmatched
- Quality Controlunmatched
- Records Managementunmatched
- Regulationsunmatched
- SAP ECC (fka SAP R/3 and SAP ERP)unmatched
- Safety/Work Safetyunmatched
- Standard Operating Procedures (SOP)unmatched
- Team Lead/Managerunmatched
- Team Playerunmatched
- Technical Writingunmatched
- Time Managementunmatched
- Training/Teachingunmatched
- Writing Skillsunmatched
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