SalaryUSD $97.54 - $109.73 per annum 97.54 - 109.73 per annum
Title: Contract Senior Quality SpecialistLocation: Boston, MADuration: 6+ Month contractAbout the Company: A global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases.Benefits: Real Staffing offers medical, dental, vision, 401K, voluntary life insurance, short term/long term disability.About the Role: The Temporary Sr. Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Temporary Sr. Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product disposition. This position reports to Sr. QA Manager Your Main Responsibilities:
- As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to operations at the Vertex in the following key areas/activities; support of manufacturing operations across all phases of development and commercial, support of analytical laboratory operations, and materials management
- Responsible for reviewing batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
- Responsible for dispositioned product labelling and coordinating with Materials Management to support product shipment.
- Responsible for archival of batch records and other supporting documents in QDoCCs
- Provide production floor support and guidance on any manufacturing related issues for GMP Continuous and non-continuous product manufacturing.
- Review and approval of Manufacturing documents (as required)
- Responsible for raw material release, area clearance, line clearance and equipment release
- Provide QA support of change controls, GMP investigations and CAPAs (as required). Responsible for updating QA database to support generating performance metrics, trends.
- Participate in compliance walkthroughs and help drive the closure of any observations
- Responsible for identifying risks and communicating gaps for GMP process/systems
- Responsible for identifying risks and communicating any gaps for quality processes optimization for area/equipment release, material disposition, quality systems etc.
- Participate in inspection readiness and support activities (as necessary)
- Participate in process improvement initiatives (as necessary).
- Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issue in a timely manner
- Experience providing QA support and oversight of Material Management operations including incoming material release.
- Experience with drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge of the following in a pharmaceutical setting:
- cGMP's and associated CMC regulatory considerations
- experience with continuous manufacturing a plus
- Experience with network based applications such as Oracle, TrackWise, VeeQMS
- Experience providing QA support and oversight of GMP manufacturing operation including batch release
- Master's degree with 2-3 years of relevant work experience, or Bachelor's degree in a scientific or allied health field with minimum 5 years of relevant work experience, or relevant comparable background.