Senior Technical Writer

Technical Writer

cGMP Consulting, Inc. is seeking mid and senior level technical writers to investigate and report on deviations to the manufacturing process, customer complaints on finished product, and other manufacturing problems as assigned. Knowledge and application of the CFR's and cGMP's is preferred.

cGMP Consulting is looking for an individual who is efficient, comfortable working independently, and who will handle multiple projects and priorities, work with tight deadlines, address high priority requests, and will be expected to “roll up your sleeves” to problem solve and move productively. The ideal candidate for this job is resourceful, independent, organized, and capable of working in a fast-paced environment. Assuring a steady and accurate completion of the workload on time is key to success in this position.

Responsibilities

• Responsible for describing problems, identifying possible causes, collecting and organizing existing data, comparing causes to facts, identifying probable root causes, and determining the best solutions in order to control the manufacturing process.
• Responsible for managing multiple deviation investigations simultaneously.
• Provide follow up and scheduling to ensure batch release process is not impacted by outstanding deviations.
• Ensure investigations will withstand regulatory scrutiny and are compliant with cGMP regulations.
• Work with process experts and production personnel to fully understand and solve problems.
• Provide technical expertise and recommends improvements.
• Write Impact Assessments and Investigation reports, work within electronic quality system.
• Assign corrective/preventive actions (CAPAs) as necessary in order to resolve problems.
• Perform continuous review and follow-up on investigations to minimize overall product impact and ensure the timely disposition of product that is directly affected.
• Inform Management on the progress of on-going investigations, provide information to and takes direction from the Deviation/Material Review Board.
• Provide support in completing SOP changes as directed by the Investigation conclusions.
• Participate in and lead Deviation and Material Review Board (DMBR) and Quality Improvement Team (QIT) meetings to identify corrective actions to prevent repeat deviation recurrences.
• Utilize Word, Visio, Excel, Documentum and other electronic systems to complete tasks.
• Maintain compliance with company policies, training requirements, cGMP's and safety standards.
• Perform any other tasks/duties as assigned by Management.
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Requirements

• 2 - 5 years experience
• Minimum 4-year degree in Engineering or related field.
• Ability to read and translate blueprints and technical drawings.
• Basic understanding of building design and mechanical processes.
• Ability to work as part of a team and individually on projects.
• Working knowledge of cGMP practices including Good Documentation Practices. Working knowledge of FDA, USP, ISO, and ISPE trends and guidelines.
• Excellent time management skills.
• Strong communication skills.