Our client is an established quality health products developer for the consumer market worldwide. They are looking to add a
Technical Writer to their team.
Salary/Hourly Rate
Depending on experience
Position Overview
The successful Technical Writer will coordinate lab validation and technology transfer activities and provide guidance and technical advice to analytical staff in written and oral communications. The Technical Writer will support QC lab investigations and write QC lab testing methods and lab reports, validation protocols, validation reports for method qualifications/transfers/verifications, stability protocols & reports for raw materials and finished products.
Responsibilities Of The Technical Writer
- Perform technical writing for QC & analytical validation/qualification/technical transfer/verification protocols based on applicable validation regulations.
- Perform technical writing for stability protocols based on applicable ICH guidelines and FDA regulations.
- Ensure proper recording of raw data and results and maintain updates on electronic records.
- Perform technical writing for QC & analytical lab test methods and SOPs.
- Coordinate with QC, Analytical, Microbiology, and clients to design specific validation & stability protocols to suit individual project needs.
- Liaise with QA on quality issues in the protocol creation process.
- Assist in writing related to QA documentation including change controls, deviations, CAPA, and OOS investigations, and assist in review of material specifications.
- Maintain accurate files and records. Ensure digital integrity.
Qualifications For The Technical Writer
- Experience in GMP protocol technical writing in pharma or related industries.
- Computer & technical writing skills.
- Database management and project management experience.
Education Requirements
- Master’s degree in Chemistry, Biology, or a related field is required.
Benefits
- Client-provided benefits available, upon eligibility.
As a woman-owned firm, we value diversity. We are an equal opportunity and affirmative action employer and will consider all applications without regard to race, sex (including gender, pregnancy, sexual orientation and gender identity), age, color, religion or creed, national origin or ancestry, veteran status, disability (physical or mental), genetic information, citizenship or any other characteristic protected by law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Candidates who apply for roles through the Atrium website will be added to our candidate pool and may be considered for additional roles of a similar title. Please contact us to request an accommodation.
EOE/M/F/D/V/SO
Position ID: 149343