QC Technical Writer

Quality Control Scientific Writer

12 month initial contract- temp to permanent

$27-$30/HR based on health insurance

8am-5pm

Austin, TX

Orion Group is now seeking a Quality Control Scientific Writer for our intravenous medical device manufacturer in Austin, TX.

• The Quality Control (QC) Scientific Writer drafts procedures, protocols, and investigation (CAPA) documents in support of day-to-day QC laboratory operations.
• The QC Scientific Writer will ensure the document is progressed through its lifecycle either manually or in the appropriate system of record.
• The QC Scientific Writer will oversee daily updates of document trackers/ spreadsheets to ensure target dates are met.

Quality Control (QC) Technical Scientific Responsibilities:

• Draft and process procedures, protocols, and investigation (CAPA) documents through the expected lifecycles either manually or in the appropriate system of record.

• Conduct CAPA investigations or NCR into process excursions, procedural exceptions, and nonconforming events.

• Perform data trending analysis of laboratory test data.

• Prepare and manage departmental metrics including daily updates of document trackers/ spreadsheets to ensure target dates are met.

• Ensure accurate timelines are maintained and communicated to management.

• Adhere to all company guidelines and procedures and ensure required compliance training is up to date.

• Perform other related duties as assigned or required.

Quality Control (QC) Technical Scientific Qualifications:

• Strong communication and organizational skills.

• Ability to communicate with all levels of management.

• Must possess strong technical writing skills.

• Has used standard office applications such as Microsoft Word, Power Point, Excel.

• Problem solving will be addressed in two specific ways: People and Processes.

• In the area of people, must be able to foster a participative approach to problem solving.

• Must also be able to build an atmosphere of trust, open communication, and respect in order to handle the difficult issues in investigations and corrective action follow up.

• In the area of processes, will be required to utilize technical expertise to identify and understand problems that may elevate to serious compliance issues.

• Must be at least 18 years of age.

• High School Diploma required.

• 2-year or 4-year degree from an accredited college or university is preferred.

• Courses or specialization should include chemical sciences, microbiology, or biological sciences.

• Requires 0-2 years of experience in technical writing and/or laboratory experience.

Quality Control (QC) Technical Scientific Work Environment:

• General office conditions with occasional entry to laboratories, warehouse, manufacturing, and clean-room manufacturing spaces.

• This job operates in a professional office environment and routinely uses standard office equipment.

• Occasional lifting of standard office items. Must be able to lift up to 25 lbs. unassisted.

• Typically requires travel less than 5% of the time.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.