FSP-Scientific/Technical Writer Job at Confidential, King of Prussia, PA

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  • Confidential
  • King of Prussia, PA

Job Description

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.

Job Tags

Remote job, Full time, Work at office

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