Quality Assurance Specialist Sagent Pharmaceuticals
THIS JOB HAS EXPIRED Department:
Quality & Facility Compliance
Associate Director of Quality Assurance or Quality Assurance Supervisor
To provide Quality Assurance support and guidance for new product launches, new chemical source evaluation and approval and process improvement projects. Work with our Contract Manufacturing Organizations (CMO) to ensure Sagent?s standards and requirements are met for product shipments. Proactively support the existing quality systems including training, writing policies and procedures, and benchmarking cGMP requirements to decrease the likelihood of action resulting from a regulatory inspection.
- At least 3 years progressive challenging QA/QC experience in the pharmaceutical or related industry.
- Excellent knowledge of current GMP and GLP as well as FDA trends and guidelines.
- Must possess exceptional communication and interpersonal skills.
- Must have excellent organizational and project management skills to coordinate multiple projects.
- Review and approve Batch Records.
- Review all documentation supporting shipment of product manufactured for Sagent prior to shipment, including temperature profiling data.
- Review QC data, CoA, CoC and Specification sheets.
- Provide guidance and support in all aspects of cGMP to our CMOs including in particular good documentation practices and root cause analysis during investigations.
- Generate protocols and final reports supporting package integrity and temperature profile assessments. Manage execution of such protocols and reports.
- Maintain databases for Deviations, Customer Complaints, Adverse Events, OOSs and Investigations.
- Review and approve Change Control related to GMP documentation, including labeling.
- Review Deviation and Investigation reports.
- Provide on-going support to the existing Sagent QMS and training program and implement new procedures and policies as necessary.
- Track & trend quality reports for root causes and create reports for distribution.
- Act on Associate Director of Quality Assurance?s of Supervisor?sbehalf, as designated.
Specific Technical/Job-Related Skills:
- In depth knowledge of current GMP and GLP as well as FDA trends and guidelines.
- Expertise in microbiology, aseptic processing, and terminal sterilization processes.
- Possesses strong organizational skills for prioritizing workload and responsibilities.
- Strong written communication, interpersonal, negotiations and problem solving skills are required.
- Proficient with PC-based word processors, databases and spreadsheets.
||Schaumburg, IL |
THIS JOB HAS EXPIRED