- 189952 - Technical Writer
- St. Louis
- 6 mos
- Chipton-Ross is seeking a Technical Writer for an opening in St. Louis, MO.
The Scientist II (QC Analytical Technical Writer) will be responsible for preparing new documents in the QC Analytical group as per ICH guidelines for Biopharmaceutical Drug Substance such as product specifications, Validation protocols/reports and Method transfer protocols/reports. He/She will also be responsible for creating/ revising standard operating procedures and test methods, as needed.
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.
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. 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
Accredited Bachelor’s Degree in a Biological Science related field
M-F, 8-5pm; weekends OT if needed
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x307 or (800) 927-9318 x307
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.