PDS Tech Inc Technical Writer in Saint Louis, Missouri
PDS Tech is seeking candidates for a Technical Writer, in Saint Louis, MO.
Authors, reviews validation and method transfer documents.
Authors/ revises QC standard operating procedures and test methods.
Authors/ revises QC data forms, and all other pertinent technical documents for QC
Bachelor’s Degree in a Biological Science related field and 5+ years related experience in biopharmaceutical or pharmaceutical industry.
Extensive knowledge of GMP regulations in cGMP manufacturing environment.
Working Knowledge of scientific principles for wide range of analytical techniques strongly preferred. HPLC and ELISA experience with large molecules is preferred.
Routine use of MS Excel, MS PowerPoint, and MS Word is essential
Knowledge, Skills, Abilities:
Ability to understand customer requirements related to Quality control, including processes and equipment.
Outstanding technical writing skills.
Strong interpersonal skills including actively listening, conflict resolution and the ability to effectively influence diverse stakeholders for positive outcome.
Ability to build strong relationships with client while instilling trust and confidence
Highly organized with attention to detail
Knowledge of Qualification and Validation requirements for analytical methods
Working knowledge of cGMPs and Quality Control regulatory requirements
Experience with authoring documents for qualification/validation of QC assays.
Performs analytical and technical troubleshooting
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.