Job Description

TECHNICAL WRITER

DESCRIPTION OF SERVICES:

As a project-based, contingent worker; the Technical Writer will be responsible for coordinating proofreading, editing and review for content development deliverables from initial conception to final release. This role works with the Program Team to routinely implement product strategies, and to support program needs while adhering to established harmonization and reuse guidelines.

SCOPE; ACTIVITIES, TASKS:

Technical Writer will perform the following activities:

· Analyze existing procedures for concurrence with correct department methods and production records relative to company policies, governmental regulations and license requirements. Specifically documents related to test methods, batch records, material specifications, standard operating procedures, and manufacturing and laboratory forms.

· Write procedures that reflect the most effective systems within company policies and government regulations to reduce misunderstanding and usability.

· Write procedures with appropriate details that are easily understood and readily usable for consistency in training.

· Respond to audit items specifically related to test methods, batch records, material specifications and standard operating procedures.

· Work with Pharmaceutical Technology, Analytical Development, Manufacturing, Laboratories and Contract Customers to gather information as requested for inclusion in their procedure, method, specification, or batch record.

· Reviews product change request information for correct presentation, completeness, and impact.

· Determine if existing documentation/procedures:

· Current and that there is consistency between similar documents.

· Meets internal control policies and regulations.

· Changes are required to current procedures based on investigation, audit responses, developmental, or compendia revisions.

· Is/are required or redundant.

· Maintain Standard Operating procedures related to Laboratory test procedures, Material Specifications, and Batch record related documents.

· Assist in developing department safety objectives and promote safety consciousness, adherence and safe work habits within the department.

· Assist the department Director in managing the physical preparation, approval and maintenance of all master batch documents and product history files for plant location, including all support documents to comply with procedures, policies and regulations.

· Assist the department Director review and approve master batch documents for production in accordance with regulatory, internal requirements and product modifications.

· Assist manufacturing personnel and laboratory analysts develop and analyze procedures and/or forms to improve product/quality control needs to increase efficiency and improve yields and reduce costs.

· Collaborate with production, Regulatory Affairs, Compliance, Quality Assurance and other personnel on technical problems and/or requirements and recommend policies, systems, tests and standards for product control.

· Review and approve GMP training guides in accordance with regulatory and company policies.

·

SCHEDULES; DELIVERABLES:

CONTINUOUSLY THROUGHOUT THIS PROJECT:

· Analyze existing procedures for documents related to test methods, batch records, material specifications, standard operating procedures, and manufacturing and laboratory forms.

· Write procedures with appropriate details that are easily understood and readily usable for consistency in training, within company policies and government regulations to reduce misunderstanding and usability.

· Responds and provides requested documentation to audit items specifically related to test methods, batch records, material specifications and standard operating procedures.

· Work with multiple departments and contract customers to gather information as requested for inclusion in their procedure, method, specification, or batch record.

· Maintain Standard Operating procedures related to laboratory test procedures, material specifications, and batch record related documents.

· Assist the department/management in the review and approval of master batch documents for production in accordance with regulatory, internal requirements and product modifications.

· Review and approve GMP training guides in accordance with regulatory and company policies.

· Assist in the control and maintenance of the company's master database of stock titles and numbers for raw materials, intermediates, packaging materials to improve product control; maintain databases related to control documents.

· Reviews standard operating procedures, license requirements, USP and other government regulations related to revisions and new documentation.

· Initiates the necessary change controls to maintain compliance and revise existing documentation.

· Participates in FDA, CBER, and Contract Customer audits in regards to test methods, material specification, forms, and batch records.

· Review requested form revision and impact of the change against SOP, batch cards, test method. etc.

QUALIFICATIONS:

• Bachelors’ Degree required in Science, Mechanical Engineer
• 3 or more years of experience in medical device development (technical writing) and has a solid grasp of manufacturing process equipment and cGMP.
• Must be able to work in a fast paced environment
• Strong analytical and problem solving skills
• Self-Motivated with a proven record of taking the initiative
• Able to work with minimal supervision
• Proficient with Microsoft Office Applications – Word, Excel, Access, PowerPoint, Outlook, Visio, etc.
• Good written communications skills
• Good customer service skills, including phone skills
• Strong verbal and interpersonal skills
• Has strong interpersonal skills and ability to communicate with diverse groups and individuals

Company Description

We’re committed to empowering each individual who works with us to take charge of their career. You won’t be alone on your journey. Our dedicated team is here to serve you as a partner in the process. What we offer for you: Interview preparation Resume review and recommendations LinkedIn review Local job market information, trends, and insights Access to networking events Informational career centric seminars. Neteffects Consultant Care Program: Keeping in Touch: Whether it’s a quick call or email, coffee or lunch, our check-ins support as much or as little interaction as you’d prefer. We’re here if you need us. Events: Neteffects participates in a number of events each year and hosts some employee-only social gatherings. Remarketing: When your project is nearing completion, we’ll partner with you to get you ready to engage in your next consulting opportunity through Neteffects. From resume review, to interview preparation and offer negotiation; we’ll work hard to help you excel. Neteffects Benefits: Neteffects is about celebrating technology and the pro's that come with it. We offer a very competitive benefits package, which includes Medical, Dental, Vision, Life, 401k, and more. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.