ERT is looking to hire a Quality Technical Writer for either our Philadelphia or Pittsburgh offices.
Serve as a key resource for the development of client facing Investigative reports for the Quality Unit.
Assist with the implementation and maintenance of Quality Management Systems (QMS).
Manage Corrective Action and Preventive Action responses received for internal and vendor audits, and responses defined for external audit observations. Conduct follow-up with the applicable departments to ensure timelines for corrective actions are met.
Assist on an Ad Hoc basis with development and review of regulatory observation responses and regulatory correspondence
Creation and documentation of new flows, procedures, documents, training, and other support materials. Responsible for assisting Quality Unit with updates to Standard Work Instructions and Standard Operating Procedures.
Provide support in the development of education and training programs related to Operational Quality processes.
Manages multiple QA tasks in parallel and effectively prioritizes tasks to align with corporate quality objectives. Effective time management, tracking deliverables and when necessary, escalations to supervisor.
The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. ERT reserves the right to amend or change this job description to meet the needs of ERT. This job description and any attachments do not constitute or represent a contract.
Qualifications: Writing Sample Required for this position.
Bachelor's Degree, preferably in a Scientific or Technical Field.
Knowledge of 21CFR Part 11, 21 CFR 820.20, ISO 9001/13485 and applicable regulatory authorities preferred
Must have 2 to 5 years of related experience, preferably in a technical writing position, within a FDA regulated industry environment.
Must have prior experience in a Quality Assurance role. Knowledge of GDP and GCP required.
Experience with Quality Management Systems, and CAPA preferred.
Exceptional written and verbal communication skills, attention to detail. Strong working knowledge of editing, proofreading, spelling, grammar, and punctuation. Skilled at organizing information into a clear and concise written form. Ability to work independently as well as in a team environment.
Proficient in Excel
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.