Technical Writer - Johnson Service Group

Johnson Service Group (JSG) is currently looking for Technical Writer with experience with SOPs, batch records. This is a  1year to 18 months contract opportunity with a multinational pharmaceutical and biotechnology company located in Marietta PA. The position will be 100% onsite.

Pay: $45/hour

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.

KEY RESPONSIBILITIES:
Quality & Compliance: Support integration of overarching Manufacturing systems and procedures to achieve inspection readiness at all times. Promote a quality mindset and quality excellence approach to all activities. Adhere to all 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.

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 Admins to ensure documents are submitted for upload into eSOP in an accurate, timely manner.
• Monitor document cycle time and escalate overdue tasks as required.

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

Johnson Service Group, Inc. (JSG) is a North American leader in the staffing and consulting services industry, with over 35 years of experience investing in people and companies.

Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.

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