Technical Writing Specialist - OQSIE
Irvine, CA 92614
About the Job
Develop and create accurate Good Manufacturing Practices (GMP) technical documents.
Skills:
Develop and create accurate Good Manufacturing Practices (GMP) technical documents. Key Responsibilities: • Provide technical writing expertise to create complex design control documentation packages including process validation documents (e.g, Installation Qualification, Operations Qualification, Process Qualification) Good Manufacturing Practices (GMP) protocols and reports, technical summaries, and test procedures • Collaborate with stakeholders (e.g, production employees, technicians, engineers, project teams, regulatory teams and management) to develop an understanding of the product, component, or device changes • Maintain documentation in a standard format following established guidelines • Review documents for style, clarity, grammar, and punctuation • Identify and correct inconsistencies of thought, development, or organization and confer with authors to recommend an appropriate adjustment in documents and procedures • Recommend improvements to current documentation practices and propose recommended changes • May lead special projects (e.g implementation of new style of documentation procedures) • Other duties assigned by Leadership; Provide guidance and training to lower level employees
Education:
Education and Experience: Bachelor's Degree or equivalent in related field, 4 years experience technical writing Required And biotechnology industry (e.g., Quality Assurance, Regulatory) Preferred Additional Skills: • Proven expertise in Microsoft Office Suite including Word, Excel, Powerpoint, and Publisher; Adobe and Photoshop preferred • Excellent editing and proofreading skills • Excellent written and verbal communication skills in English including negotiating and relationship management skills • Excellent problem-solving and critical thinking skills • Full knowledge and understanding of policies, procedures and guidelines relevant in the development of technical documentation • Full knowledge of documentation (e.g, procedures, routers, process sheets, technical summaries, protocols, and test reports) • Excellent technical writing skills • Full knowledge of product assembly procedures • Ability to manage competing priorities in a fast paced environment • Strict attention to detail • Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on projects • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
Skills:
Develop and create accurate Good Manufacturing Practices (GMP) technical documents. Key Responsibilities: • Provide technical writing expertise to create complex design control documentation packages including process validation documents (e.g, Installation Qualification, Operations Qualification, Process Qualification) Good Manufacturing Practices (GMP) protocols and reports, technical summaries, and test procedures • Collaborate with stakeholders (e.g, production employees, technicians, engineers, project teams, regulatory teams and management) to develop an understanding of the product, component, or device changes • Maintain documentation in a standard format following established guidelines • Review documents for style, clarity, grammar, and punctuation • Identify and correct inconsistencies of thought, development, or organization and confer with authors to recommend an appropriate adjustment in documents and procedures • Recommend improvements to current documentation practices and propose recommended changes • May lead special projects (e.g implementation of new style of documentation procedures) • Other duties assigned by Leadership; Provide guidance and training to lower level employees
Education:
Education and Experience: Bachelor's Degree or equivalent in related field, 4 years experience technical writing Required And biotechnology industry (e.g., Quality Assurance, Regulatory) Preferred Additional Skills: • Proven expertise in Microsoft Office Suite including Word, Excel, Powerpoint, and Publisher; Adobe and Photoshop preferred • Excellent editing and proofreading skills • Excellent written and verbal communication skills in English including negotiating and relationship management skills • Excellent problem-solving and critical thinking skills • Full knowledge and understanding of policies, procedures and guidelines relevant in the development of technical documentation • Full knowledge of documentation (e.g, procedures, routers, process sheets, technical summaries, protocols, and test reports) • Excellent technical writing skills • Full knowledge of product assembly procedures • Ability to manage competing priorities in a fast paced environment • Strict attention to detail • Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on projects • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
Source : OQSIE
