Technical Writer

Description of Services:

Technical Writer will prepare new and revised documents such as forms, standard operating procedures, and batch records. Ensure content accuracy and conformance to established standards. They will assist the department Manager in the overall direction, coordination, preparation and approval of controlled documentation, which will result in the affectivity and control of quality manufactured products, in accordance with production operating systems, procedures, compendia and quality control standards.

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 controlled drawings, supplier plans, 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.

· Support gap assessments process.

· Work with Area Owners and SMEs to gather information as requested for inclusion in their procedure, method, specification, or batch record.

· 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.

· Assist the department Area Owners and SMEs in managing the physical preparation, approval and maintenance of all records including all support documents to comply with procedures, policies and regulations.

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

· Collaborate with production, Regulatory Affairs, Compliance, Quality Assurance and other personnel on technical problems and/or requirements as needed during gap assessment process.

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

· Collects and analyzes the information necessary to complete the creation and revision of technical documents, test methods, material specifications, forms, batch records, protocols and reports.

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

· Reviews the impact of the proposed changes with regards to other support documents.

Status Meetings and Reports:

Daily reports to management as required. Weekly progress reports will be supplied to Company management outlining all activities, current status and estimated completion dates.

Schedules; Deliverables:

Continuously throughout this project:

· Analyze existing procedures for documents related to controlled drawings, supplier plans, 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, batch record, and/or gap assessment process.

· 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.

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

(***experience with these things is key)

Qualifications:

· Bachelors’ Degree preferred

· 3-5 years of experience in pharmaceutical industry (Pharma, Bio, Med Device) and has a solid grasp of manufacturing process equipment and cGMP. (most important requirement)

· ERP deployment experience or large enterprise IT applications or equivalent preferred.

· Must be able to work in a fast pace environment

· Strong analytical and problem solving skills

· Self-Motivated with a proven record of taking 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