GMP Technical Writer
220, East Hanover Avenue Morris Plains NJ USA 07950 Morris Plains, NJ 07950 US
The Technical writer is responsible for creation, development and maintenance of GMP documents, SOPs, validation protocols/ reports in support of manufacturing production. This role will ensure that all documents are updated, trained, and effective in alignment with the site needs.
- Develop comprehensive documentation that meets standards
- Liaison with MS&T, MU, QC, QA and all cross functional teams to support GMP documents
- Stay current regarding industry standards
- Support development and roll out of new Product launches
- Revise existing or create new GMP documents to support Site strategy
- Ensure periodic review is completed on time
- Ensure proper training is determined at the time of document creation
- Develop training plans in alignment with Training
- Support the design. Build, implementation and maintenance of GMP electronic systems
- Author and drive Technical Documents
- Perform gap assessments and make necessary changes to current processes
- Obtain clear understanding of product and process and translate to succinct content for the end user within the documentation structure.
Project Management Establishes and governs effective timelines and maintains progress of projects Compliance Ensures that all planned, executed, and documented activities are aligned with the company, site, and platform objectives. Ensures adherence to all company policies and procedures relating to current Good Manufacturing Practices, Standard Operating Procedures and Health, Safety and Environmental Protection regulations.
Builds credibility within the group by performing high quality work and identifying opportunities to improve workflow Strong verbal and written communication skills Comfortable multi-tasking in a fast-paced environment
Key Performance Indicators: Timely delivery on commitments and departmental KPIs Efficient and flexible usage of the available resources Compliance to all relevant company policies and guidelines Exhibiting core values and behaviors and fostering these within the team
Education: BS in biology, chemistry, biochemistry, microbiology or other related science or relevant work experience Languages: English
Experience: Experience in technical writing support function.
Preferred: 3-5 years of experience. Ability to plan, prioritize and execute multiple tasks simultaneously under tight deadlines Ability to prioritize and execute multiple tasks simultaneously under tight deadlines Ability to manage projects and lead teams utilizing modern project management methodology and tools. Strong verbal and written technical communication skills Strong interpersonal skill Proficiency using MS Word, Excel, and MS project Knowledge of cGMP, USP and FDA guidelines. Experience with Document Management system Ability to communicate clearly with a variety of individuals in various aspects of operations. Detail-oriented with expertise in problem solving and solid decision-making abilities. Strong written and verbal communication skills are essential.
Specific Professional Competencies:
- Thorough understanding of cGMP requirements Excellent organizational and communication skills Excellent interpersonal skills including use of tact, diplomacy, discretion and judgment. Ensure customer satisfaction and react to customer requests Ability to work effectively in an autonomous fashion Results-driven and goal-oriented work ethic
- Others Strong ability to work independently and compliantly Strong analysis and decision-making skills surrounding documentation Pays attention to detail Able to proof work and identify non-standard format or wording, and errors within documents
- Pay rate range: $27 - $34.78
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.