Technical Writer II

Description

Reports To:

Senior Manager, Technical Operations

Department:

Quality Assurance

Create, maintain, and revise, forms, standard operating procedures, batch records, and material specifications to improve efficiencies while enhancing company GMP compliance. Author and collaborate with authors/initiators of Manufacturing/Packaging/Laboratory Notice of Events (NOEs) and Investigations and subsequently identify appropriate Corrective And Preventative Actions (CAPAs).

Conduct cross functional investigations, deviations, and product complaints related to the site. Determine and implement appropriate corrective and preventative actions based on the outcome of investigations.

Analyze existing procedures for alignment with department methods and production records relative to company policies, governmental regulations and license requirements. Specifically, documents related to batch records, standard operating procedures, and forms. Identify opportunities for improvement and implement.

Collaborate with authors of the procedures that reflect the most effective systems within company policies and government regulations to improve employee understanding and enhance usability without error.

Work with cross-functional teams to gather information as requested for inclusion in their procedure, specification, or batch record.

Collaborate with the Training group to identify gaps/opportunities for improvement that are identified regarding personnel training that result from investigation findings.

Perform other duties as required.

Demonstrated ability to work in a team-oriented environment.

Must have ability to analyze complex technical and process data, understand verbiage and intent of Governmental and Company regulations, evaluate potential solutions, and determine the most compliant and cost-effective approach to solve problems.

Experience in oral solid dosage and semi-solid pharmaceutical manufacturing and packaging equipment. Knowledge of cGMPs and FDA requirements (21 CFR 210 and 211). Computer knowledge, good writing skills, and technical writing experience. Working knowledge of associated industry guidance documents and FDA guidelines. Expert knowledge in good documentation practices (cGDP).

Ability to prepare, analyze and review data and specifications. Proficient with the MS office suite.

Ability to analyze and interpret technical procedures and government regulations. Ability to design effective testing protocols through solid reasoning and problem solving skills.

Capable of determining appropriate Corrective Action/Preventative Action (CAPA) for recommendation to management.

To perform the job successfully, an individual should demonstrate the following competencies:

Takes the initiative to uncover the root cause of an issue and find a quick and thorough solution. Gathers and analyzes information skillfully.

A robust working comprehension of the theory and function of pharmaceutical production equipment used in oral solid dose OSD and semi-solid manufacturing and packaging is required. Ability to read and interpret technical specifications, blueprints, drawings and operating instructions.

Excellent verbal communication skills. The ability to listen and to understand information and ideas presented. The ability to communicate information and ideas in speaking so others will understand, regardless of job level.

Excellent written communication skills. Writes concise reports with attention to detail. Communicates well within all employee levels.

Works with integrity and ethically maintains confidentiality. Projects…