Technical Writer II in Bristol, Tennessee at Gregory Pharmaceutical Holdings Inc

Reports To:

Senior Manager, Technical Operations

Department:

Quality Assurance

Summary:

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).

Essential Duties and Responsibilities:

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.

Knowledge Necessary to Perform the Job:

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.

Competency:

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

Problem Solving:

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

Technical Skills:

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.

Oral Communication:

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.

Written Communication:

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

Ethics/Professionalism:

Works with integrity and ethically maintains confidentiality. Projects a professional and courteous business demeanor. Quickly adapts to the actions of others and adjusts reactions accordingly.

Organizational Support:

Supports organization’s goals and values. Follows policies and procedures.

Adaptability:

Ability to deal with changes to schedules, delays or unexpected events.

Attendance/Punctuality:

Maintains regular and punctual attendance.

Initiative:

Excellent interpersonal, communications and organizational skills as well as the ability to work independently.

Quality:

Observes company Quality policies and procedures. Makes suggestions where needed to improve processes currently in place.

Safety and Security

Observes safety and security procedures. Makes suggestions where needed to improve processes currently in place.

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or abilities required of the position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience:

Bachelor’s degree in a science/engineering related field and at least five years of manufacturing or packaging pharmaceutical experience in a GMP environment, or equivalent combination of education and experience.

Language Ability:

Ability to read, analyze and interpret SOP’s, safety rules, equipment manuals and translate equipment operational limits into protocol acceptance criteria. Strong technical writing skills. Ability to effectively and concisely present ideas and information.

Math Ability:

Ability to calculate figures and amounts such as averages, proportions, percentages, area, circumference, and volume. Apply concepts of basic algebra, geometry and statistics.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills:

To perform this job successfully, an individual should have advanced computer skills with Word, Excel, Access, Outlook and ability to use internet tools. Ability to import and extrapolate data from datalogging systems.

Work Environment and Physical Demands:

The work environment characteristics and physical demands described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in this work environment is usually moderate. While performing the duties of this job, the employee is occasionally required to stand, walk, sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include ability to adjust focus.