Senior Quality Control Analyst - Raw Materials Xcellerex

Job Hours: Full-time, Monday - Friday and off-shift as required
Position Reports to: Quality Control Manager
Summary
In this hands-on position, the Senior Quality Control (QC) Analyst will perform a wide variety of activities required for Good Manufacturing Practices (GMP) Quality Control, including but not limited to: raw materials testing, sample management, data management and QC inventory control. Responsibilities include ensuring that the scientific quality and the current GMP work performed are compliant with current regulatory standards. As the company grows, this position may assist with training, implementation of continuous improvement activities and the creation and revision of cGMP compliant documentation.
Essential Functions
? Performs in-house raw materials sampling, inspection and testing; coordinates outsourced testing and assembles documentation for raw materials release
? Maintains QC sample tracking and inventory systems
? Works with warehouse staff to ensure proper cycle times on materials
? Generates raw materials specification documentation
? Supports customer audits by representing functional area
? Performs assays in support of manufactured products
? Prepares standard operating procedures for equipment operation and qualification
? Carries out other duties as assigned by supervisor
Knowledge, skills and abilities
? Experience in quality control in the biotechnology and/or pharmaceutical industry
? Team player with well-developed interpersonal skills
? Outstanding attention to detail
? Strong organizational, planning and verbal and written communication skills
Minimum qualifications
? A Bachelor of Science degree in biomedical science or chemistry and at least five years of experience in GMP Quality Control
? Experience in raw materials sampling, inspection, testing and release
? Understanding of current Good Manufacturing Practices (cGMPs)
? Experience with MS Word, and MS Excel as a data management tool
? Must be able to be flexible as workload dictates; extra support time may be required and individual will need to be on-site in support of manufacturing needs

Location:	170 Locke Drive Marlborough, MA 01752 United States