FSP-Scientific/Technical Writer
About The Position
Our client is seeking a highly motivated Sterile Manufacturing Scientific/Technical Writer. This role involves ensuring compliance with cGMPs, SOPs, and GSK standards of documentation to support sterile manufacturing. The position requires participation and oversight in the preparation of GMP/GLP documents, support for daily manufacturing activities, and accountability for reporting and maintaining metrics. The role also includes technical writing and review of various documents, ensuring data integrity, and contributing to safety and quality improvements. Collaboration, technical support, and continuous improvement are key aspects, along with a strong understanding of aseptic manufacturing principles. The writer will be responsible for problem analysis, resolution, and planning work to meet timelines, with potential for administrative tasks and occasional overtime. A commitment to teamwork and a team-based culture is essential.
Requirements
- Bachelor's degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field.
- Minimum of 2+ years of previous experience that provides the knowledge, skills, and abilities to perform the job.
- Computer skills including Word, Outlook, and ability to navigate simple website interfaces.
- Good hygiene, practice good hand-washing behaviors, and comfortable frequently using hand sanitizing agents.
- Committed team player.
Nice To Haves
- Preferred understanding of GMP manufacturing.
- Strong understanding and application of aseptic manufacturing principles.
Responsibilities
- Ensure compliance with cGMPs, SOPs, and GSK standards of documentation to support sterile manufacturing.
- Participate and oversee the preparation of GMP/GLP documents such as Standard Operating Procedures, Production Forms, batch records, Logbooks, and Laboratory Notebooks.
- Assist in the preparation of metrics and key KPIs for the area.
- Support the daily activities of the area to ensure the manufacture of quality parenteral products for development and clinical needs.
- Accountable for reporting and maintaining metrics as appropriate.
- Support the preparation, revision, and archiving of technical documents such as area rationales, templates, SOPs, equipment procedures, risk assessments, contamination control strategies etc.
- Ensure zero instances of data falsification or data integrity issues by PPD staff.
- Generate and report metrics for Sterile Ops led processes.
- Inspect work area for safety regulations and recommend improvements.
- Identify and coordinate implementation of safety, quality, and business improvements.
- Assist and contribute to GMP and safety self-inspection activities.
- Proactively communicate the status of critical compliance systems support and problem resolution.
- Lead by example in working collaboratively and embracing GSK’s Code of Conduct.
- Provide technical support and participate as a Subject Matter Expert on GQP topics.
- Apply knowledge and leverage continuous improvement activities to support adherence with industry regulations, Global Quality Policies, and business procedures.
- Lead the identification and implementation of strategies to improve the qualities and efficiencies of Sterile Ops processes and systems.
- Maintain strong systems/process understanding of current technologies and professional concepts.
- Implement new technologies/processes to the Sterile pilot plant.
- Apply knowledge and leverage continuous improvement activities utilizing available tools where applicable that support continued adherence with industry regulations, good documentation and data integrity principles.
- Ensures effective problem analysis and resolution of issues of diverse scope in a timely fashion and escalates issues when needed to appropriate levels of Sterile Ops management.
- Responsible for scheduling and planning work to meet priorities set by GSK, setting specific daily and weekly priorities to meet timelines, and recommending procedures and policies to supervision.
- Perform administrative tasks such as procedure revision, template revision, records filing, records archiving, and other tasks as needed.
- Work in and embrace a team-based culture.
- Identifies risks to business for consideration by management.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
