Apex Systems Scientist II - QC Analytical in St. Louis, Missouri
Scientist II - QC Analytical in St. Louis, MO at APEX Systems
Date Posted: 1/18/2019
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- Employee Type:
St. Louis, MO
- Job Type:
Sci: QC Tech
- Date Posted:
Job Description Job #: 931808
Apex Life Sciences is looking for a QC Analytical Technical Writer! This role is a long-term contract for a pharmaceutical company here in the St. Louis area!
This candidate will be responsible for preparing new documents in the QC Analytical group as per ICH guidelines for drug substances 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
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
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
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178