FSP-Scientific/Technical Writer

Work Schedule

Environmental Conditions

Job Description

Our client’s is seeking a highly motivated Sterile Manufacturing Scientific/Technical Writer job description which includes, but is not limited to:

Key Responsibilities:

Documentation and Compliance:

• 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.

Technical Writing and Review:

• 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.

Safety and Quality:

• 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.

Communication and Collaboration:

• 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.

Support and Training:

• Provide technical support and participate as a Subject Matter Expert on GQP topics.

Continuous Improvement:

• 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.

Additional Responsibilities:

• Strong understanding and application of aseptic manufacturing principles to implement new technologies/processes to the Sterile pilot plant.
• Application of knowledge and leveraging of 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.
• Employee may be asked to perform administrative tasks such as procedure revision, template revision, records filing, records archiving, and other tasks as needed.
• Employee has computer skills including Word, Outlook, and ability to navigate simple website interfaces.
• Employee must have good hygiene, practice good hand-washing behaviors, and be comfortable frequently using hand sanitizing agents.
• Employee may be asked to work occasional overtime hours.
• Must be a committed team player prepared to work in and embrace a team-based culture.
• Identifies risks to business for consideration by management.

Education:

Bachelor's degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field with a minimum of 2+ years of previous experience that provides the knowledge, skills, and abilities to perform the job. Preferred understanding of GMP manufacturing.