9922 Technical Writer I

Duties:
Solve a variety of routine and difficult technical writing, editing, and document administration issues following cGMP regulations and Company standards.
Provides Quality oversight and management of the document change process in an Electronic Document Management System (EDMS).

Technical:
Follow company policies and procedures.
Maintain a state of inspection readiness.
Provide input to the development of personal performance goals and departmental objectives.
Collaborate with Management to establish and meet targets and timelines.
Independently manage completing priorities with limited instruction.
Serve as a Quality representative on cross-functional and multi-site teams.
Identify and recommend solutions to potential procedure, process and system gaps.
Provide assistance to customers in support of departmental functions.
Participate in the design and implementation of department and cross-functional initiatives.
Apply basic theory and technical principles to address moderately complex problems.
Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
Serve as a technical subject matter expert (SME) in support of department functions.
Sign documents for activities as authorized and described by the Company’s policies, procedures and job descriptions.
Be accountable for behaviors as described in Company’s Core, Common and Critical Competencies.
Perform any other tasks as requested by Management to support Quality oversight activities.
Create and edit controlled documents at all levels of complexity consistent with current formats and department style guides using the Electronic Document Management System (EDMS).
Evaluate and prioritize assigned document workload to meet internal productivity targets.
Partner with other change control groups to coordinate other changes as necessary (documents, other systems, and equipment) Support the Document Audit programs (DAR and CDM) and identify issues.
Represent department on interdepartmental project teams.
Track and communicate the status of document changes and projects.
Enforce document and change control policies and procedures.
Ensure document changes have the appropriate level of assessment and approval.
Generate department performance matrix to monitor achievement of goals and objectives.
Participate in document change control process improvement initiatives.
May perform final review of document changes.
May train new hires and internal customers.
May participate in generating data for agency and third party audits.
Skills:
Knowledge of cGMPs or equivalent regulations strongly preferred.
Ability to interpret Quality standards for implementation.
Ability to independently evaluate situations and propose potential solutions.
Ability to interpret Quality standards for implementation.
Ability to communicate clearly and professionally both in writing and verbally.
Flexibility in problem solving and work hours to meet business objectives.

Education:
B.A. or B.S. degree (preferable in Life Science) At least two years experience in the pharmaceutical, biopharmaceutical or related industry, or an equivalent combination of education and experience.