Technical Writer (BBBH12408) Franklin, Ohio
The world's largest research-based pharmaceutical company is hiring! Our client discovers, develops, manufactures, and markets leading prescription medication.
For over 150 years, they have been making the world a healthier place to live.
- Create new or revise existing content for SOPs, equipment validation and regulatory submissions with a high degree of quality in accordance with cGMP requirements and corporate guidelines;
- Complete gap assessments between Corporate Standards and Site SOPs;
- Experience in authoring documents as part of manufacturing, processing, testing, holding and distribution of pharmaceutical or biological products;
- Review, edit and proofread materials written by others as applicable;
- Analyzes technical literature available, writes descriptive copy, and verifies documentation;
- Review and revise existing documentation to assure it remains current;
- May perform other duties such as: Controlled document archival (scanning, filing, etc), Issuance of controlled documents, Miscellaneous administrative tasks as needed.
EDUCATION & EXPERIENCE:
- Bachelor Degree in Science preferred;
- Experience in a Quality Control environment;
- Knowledge of GMP and/or ISO standards;
- Experience in biotech and/or pharmaceutical manufacturing environment an asset;
- Minimum two 2 to five 5 years related experience in technical writing;
- GxP Industry Experience preferred;
- Knowledge of GxP GLP, GMP, or GCP and 21 CFR Part 11 Regulations;
- MUST HAVE AT LEAST 2 YEARS RELATED EXPERIENCE;
- Pharmaceutical Manufacturing Experience Preferred;
MOST CRITICAL SKILLS:
Documentation Experience; GXP GLP, GCP, GMP.
Skills: Good Automated Manufacturing Practices (GAMP): 4-7 Years Good Clinical Practices (GCP): 4-7 Years Good Laboratory Practices (GLP): 4-7 Years Good Manufacturing Practices (GMP): 4-7 Years
- Detail oriented with the ability to learn new concepts and apply them quickly;
- Good command of MS Office Suite (Word, Excel, PowerPoint, Outlook);
- Exceptional written and verbal English communication skills;
- Strong working knowledge of editing, proofreading, spelling, grammar, and punctuation;
- Ability to effectively communicate with all levels of management and all lines of business;
- Superb organizational and time management skills and attention to detail;
- Ability to work independently with minimal level of supervision.
Approx. Duration: 7 months
About Hired By Matrix
For more than 25 years, Hired by Matrix has been providing temporary and long-term contract staffing solutions to Fortune 1,000 as well as mid-market companies nationwide. Our clients include major pharmaceutical, delivery & logistic, business information, financial and entertainment companies. The technology that we support is as diverse as our clients. We provide consultants with experience in mainframe legacy technology all the way to cutting edge technologies, like web and mobile application development. Our consultants are in roles that include Project Managers, Architects, Business analysts, QA, developers and infrastructure & network specialists. At the request of our clients we have broadened our capabilities across a variety of different areas, including: finance and accounting, R&D, clinical sciences and administrative. And as a woman-owned, WBENC-certified business we’ve helped companies grow their Supplier Diversity spend which is certainly a nice added benefit as well.
Our extended network of qualified contract professionals offers nationwide contracting capabilities.
Our dedicated team of account managers and recruiters collaborates closely with each of our clients to understand their staffing needs, corporate requirements and company cultures before building robust, fully customized pipelines of highly-qualified contract professionals in response.