Quality Assurance Technical Writer

6 days ago

Marietta, United States LanceSoft, Inc. Full time

Description:

POSITION TITLE: Technical Writer

DURATION: 1 Year (potential for extension up to 18 months)

100% ON SITE: Monday to Friday, day shift (8 hours/day).


JOB PURPOSE:

• Serve as a Technical Writer dedicated to authoring, revising and improving documents within manufacturing. (Business processes, SOPs, batch records, checklists, etc.)

• Serve as liaison between manufacturing groups, as well as between manufacturing and support departments, to ensure accurate, compliant and streamlined controlled documents.

• Drive continuous improvement in the controlled document system and determine best practices that increase usability and practicality of documents.

• Champion standardization of documents across groups within manufacturing (e.g., content, structure, format, etc.)

• Serve as a change coordinator for projects in the manufacturing department.

• Partner with learning and development as well as Manufacturing groups to ensure documents support accurate representation of operations and provide a foundation for education and competency.

KEY RESPONSIBILITIES:

Environmental Health & Safety:


Promote a highly safety conscious culture and EHS focused workforce. Perform all job responsibilities in compliance with applicable regulations, current operating procedures, and industry practice.

Quality & Compliance: Support integration of overarching Manufacturing systems and procedures to achieve inspection readiness at all times. Ensure all activities are executed following quality and regulatory standards. Support implementation and monitoring of quality systems to achieve inspection readiness at all times. Promote a quality mindset and quality excellence approach to all activities. Adhere to all CLIENT Quality Management System (QMS) policies and procedures as applicable.

• Format and manage documents using appropriate guidelines and established document templates.

• Evaluate GMP documentation change requests to determine scope of change, and ensure accurate information in revision history (associated CAPAs, Change Controls, Impact Assessments, etc.)

• Where appropriate, manage CAPA tasks related to GMP documentation revisions.

• Determine when GMP documentation duplications exist and manage resolution and consolidation of affected documents.

Continuous Improvement:


Support Lean/Six Sigma program to drive and embed a culture of continuous improvement by the use of operational excellence methodologies to realize ever-increasing levels of value in the usability and practicality of documents;

• Partner with local Learning and Development team to drive the revision and creation of SOPs and GMP documents that enable effective training, retention of information and competency.

• Partner with Pn MAPS manufacturing team to drive the revision and creation of business processes enable effective training, retention of information and competency.

• Incorporate revisions and ensure consistent terminology and language for presentation of information.

• Partner with key stakeholders and drive continuous improvement in the controlled document system and determine best practices that increase usability and practicality of documents.

Accountability:


• Partner with LSOP Process Owners, to obtain accurate content for inclusion in documents, utilizing shop floor Gembas and process walk-downs, to drive inclusion of effective and accurate content in documents, and communicate significant GMP documentation changes in procedures to process owners.

• Partner with Doc Adnims to ensure documents are submitted for upload into eSOP in an accurate, timely manner.

• Monitor document cycle time and escalate overdue tasks as required.

Change Management:

Deal positively with change, demonstrating the ability to maintain high personal performance levels as the organization evolves. Positively influence others’ ability to adapt to change.

EDUCATION REQUIREMENTS: Bachelor’s or higher degree. MAPS production is a novel vaccine process which requires a scientific background. Practical experience in the biopharmaceutical industry is required given the highly regulated safety and quality standards.

• Knowledge of cGMP, FDA and other regulatory requirements and quality systems

• Working knowledge of SAP with demonstrated ability to learn other facets of SAP (i.e. eSOP, and change control)

• Proficient use of MS Office Suite, Visio, digital imaging

PREFERRED LEVEL OF EDUCATION: Technical Writing degree or specialized training in technical writing. MAPS production is a novel vaccine process which requires a scientific background. Practical experience in the biopharmaceutical industry is required given the highly regulated safety and quality standards.

• Knowledge of cGMP, FDA and other regulatory requirements and quality systems

• Working knowledge of SAP and MES eBR with demonstrated ability to learn other facets of SAP and MES (i.e. eSOP, eBR, eChecklist and change control). Proficient use of MS Office Suite, Visio, Arris, digital imaging

MINIMUM LEVEL OF JOB-RELATED EXPERIENCE REQUIRED: To effectively coordinate the efforts of production and supervisory staff to achieve manufacturing objectives and milestones. Demonstrated ability in the following:

• Ability to prioritize and flexibility to adapt to changing business schedules and deadlines

• Ability to coordinate projects involving multiple documents and clients

• Good communication, organizational and team skills

• Public speaking/presentation

• Ability to take initiative and work proactively with creative problem-solving skills

• Demonstrated experience driving change and delivering results with a strong commitment to individual accountability for tasks

• Strong interpersonal communication skills and ability to thrive in a dynamic team environment

• Capable of working without direct supervision

Committed team player prepared to work in and embrace a team-based culture

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