Fixed Term QC Analyst IV

DESCRIPTION

Applications are invited for the fixed-term (12 month) role of QC Analyst IV (Technical Writer) within the QC Laboratory with a focus on implementing Reduced testing on raw materials. Reporting to the QC Laboratory Supervisor, the successful candidate will be responsible for supporting the work of the QC group in accordance with GMP.

KEY RESPONSIBILITIES

• Lead QC technical documentation projects as an individual contributor (Reduced Testing Project).
• Accountable for the timely completion of projects within the technical writing role.
• Able to work independently and manage workload.
• Collaborate with internal resources and business partners to support project requirements and to ensure project completion.
• Work in accordance to cGMP and GLP requirements.
• Ensure consistent and good documentation practices are followed.
• Creation, review and update of documentation, e.g. Laboratory Technical Protocols and Reports, Standard Operating Procedures and Analytical Protocols.
• Translate complex topics into clear, concise, understandable topics as required.
• Review standards for documentation types, structure, and assembly so that content is organised logically with the end-reader in mind.
• Actively look for Continuous Improvements.
• Maintain documents in the documentation management system.
  

REQUIREMENTS

• Third level qualification (BSc or higher) in Science Related Discipline with previous experience in a pharmaceutical environment.
• Excellent communication and report writing skills, experienced at communicating complex technical topics.
• Proven Technical Writing experience in a GMP/Pharmaceutical/Quality environment and understanding of cGMP.
• Good PC skills – Word and Excel (essential), Microsoft PowerPoint and Microsoft Projects (desirable).
• Experience using Quality documentation management systems.
• Experience in deviation and investigation writing.

• Disciplined, deadline-driven and focus on Right First Time.
• Responds positively to changing circumstances and priorities.
• Ability to assimilate technical information from a variety of sources in a timely manner.
• Proven track record as a Technical Writer is essential.

Alkermes provides equal employment opportunities to all employees and applicants for employment