Vacancy expired!
Apex Systems is seeking a candidate is seeking candidates that are interested in working at a startup company. This person will be a critical member of the Regulatory Affairs and Quality team. Responsibilities:
- Manage / oversee stability program and retest for APIs, drug products and reference standards
- Contribute and Support investigation conducted at CMO/CTL and review and approve out-of-specification (OOS) and out-of-trend (OOT) testing results and deviations
- Manage review and approve changes to methods, processes (Master Batch Records) and specifications (Material and Label)
- Manage review of executed batch records, Certificates of Analysis and other documents to release drug substance and final drug product for the intended use.
- Support authoring, QC, and review of CMC sections in INDs, IMPDs, and other regulatory submissions
- Support continues improvements in quality systems (procedures and systems) to improve organization effectiveness, quality assurance compliance, and regulatory and other requirements (cGMP, ICH).
- Support Quality Systems (e.g. Document tracker maintenance; Archive electronic GMP documents; Drafting documents from template, formatting, routing for review and approval, archival)
- Other duties as assigned
- 8+ years' experience in quality assurance in the pharmaceutical industry
- BA/BS degree in related field required (or relevant experience)
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Independent decision making with a high degree of initiative
- Prior experience working with CMO / CTL
- Specialized knowledge of QA Systems and Compliance, business principles and departmental processes
- Knowledge of Drug Product and API GMP requirements and associated guidelines
- Advanced skills in using Microsoft Office Suite (Word, PowerPoint, Excel)
- High attention to detail and accuracy
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
Vacancy expired!