NEED FOR A TECHNICAL WRITER- LABORATORY EXPERIENCE NEEDEDDescription:
Preparing study archiving materials for completed studies.
Reviewing result tables against data packages
Preparation/review of assay/validation plans, reports, and methods.
Management of Bioanalytical documentation
Review of Data Transfer Agreements and work on Data Reconciliations.
Use StudyDoc to generate report templates and prepare Watson result tables
Client/FDA Audit Support
Generate, issue, reconcile, and archive batch records, protocols logbooks, and other controlled documents
Perform batch record review and work with various department to resolve and correct errors and ensure Good Documentation Practices are followed
Administer the electronic document, quality, and training management systems
Assist during all phases of the change management process
Processes and provides oversight of submitted change requests
Provides oversight of all routine reviews of documentation
Provides routine communications to the various departments and customers on outstanding tasks associated with the with the document control and change management process.
Attributes for the position:Prior experience in quality systems preferredPrior experience in pharmaceutical, GMP, or ISO manufacturing environment preferredBachelor’s Degree in a science related field or equivalent experienceExperience Level:Intermediate LevelAbout Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.