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PDS Tech Inc QC Technical Writer in High Point, North Carolina

PDS Tech, Inc. is seeking a QC Technical Writer in High Point, NC.

SUMMARY

  • Provides support to the Quality Control Department (QC) as well as Research & Development by developing, writing and editing materials for Test Procedures (TP), SOPs, and Work Instructions (WIs). and GMP batch documentation.

  • Must have outstanding attention to detail.

  • Strong technical writing and computer processing skills are required.

  • Knowledge of current Good Manufacturing Practices (cGMP) is required.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Ability to organize material and complete writing assignments according to GMP standards

  • Ability to read and understand testing protocols in order to develop testing procedures

  • Authors and revises raw material and product specifications.

  • Authors and revises analytical method validation and method transfer documents.

  • Authors and revises QC standard operating procedures, work instructions and test procedures

  • Authors and revises product elemental impurity and residual solvent assessments.

  • Authors and revises raw material reduced testing reports.

  • Authors and revises comparative raw material testing reports.

  • Utilize site eDMS to obtain review of, approval of and publication of specifications and test procedures

  • Coordinate and communicate with QC project leads and/or project management for status of project-related documents

  • Review compendial methods and current TPs/SOP/WIs and recommend/make revisions or changes in scope, format and content

  • Work closely with R&D, Product Development, Metrology, Validation and Quality Assurance

  • Review and update specifications in SAP software and provide backup for sample management if necessary

  • Performs other reasonable, related business duties

QUALIFICATIONS:

  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Additionally, an individual must uphold the standards of conduct of the company, which include confidentiality, cooperation, and respect for people and property. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION AND EXPERIENCE:

  • BA/BS or Associates degree in technical writing or related discipline and 1-2 years of technical writing experience in a Pharmaceutical industry, or equivalent combination of education and experience. Additionally, this person must have the ability to take direction as well as to provide direction to others as needed.

LANGUAGE SKILLS:

  • The document coordinator must have the ability to write simple to complex documents. Ability to review and identify errors in procedure documentation. Ability to read and interpret documents such as testing protocols, test procedures, SOPs, WIs, and procedure manuals.

MATHEMATICAL SKILLS:

  • Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to work with concepts such as limits.

REASONING ABILITY:

  • Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving a few concrete variables in standardized situation. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

OTHER SKILLS AND ABILITIES:

  • Ability to use a PC and the following software: Microsoft Office suite, MS Windows, SAP, and Documentum. Ability to make decisions. Demonstrated understanding of process and equipment in all facets of plant operations

SPECIAL REQUIREMENTS:

  • Must meet applicable DEA security clearance requirements.

PHYSICAL DEMANDS:

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function. While performing the essential duties of this job, the employee is occasionally required to walk, talk/hear/listen. The employee is frequently required to sit, reach with hands and arms, and stand. The employee is regularly required to use fingers to finger, handle, or feel. There are no lifting or special vision requirements.

WORK ENVIRONMENT:

  • The noise level is moderate.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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