SQA Quality Specialist

Summary:
Assure the quality of manufactured products are in compliance with all applicable regulations and guidelines.

Duties/Responsibilities:
• Responsible for approval of investigations and CAPAs, and CAPA Effectiveness records related to Quality Control laboratory, Environmental Monitoring, Production, and Facilities and Engineering
• Responsible for ensuring a robust investigation process in accordance with SOP's including monitoring status, notification of cGMP and quality concerns, ensuring appropriate CAPA's are assigned to address root cause and assessing impact to product quality.
• Department Lead Investigator responsible for conducting root cause analysis in accordance with SOPs.
• Assist Quality Assurance manager in tracking and obtaining information for investigations such as OAL's, OOS's and Major Quality Events.
• Responsible for monitoring and trending of investigations according to applicable SOPs. Drafts trend reports and provides Quality Assurance management with quality indicator data
• Responsible for review and approval of applicable draft SOPs and MBRs
• Responsible for backup support to drug substance and cell bank release functions.
• Responsible for backup support to Warehouse quality functions including, release of incoming consumables and raw materials, shipment verification, and documentation review
• Responsible for supporting regulatory inspections
• This position will require daily contact with all production areas and applicable support functions and represent Syracuse Quality Assurance at various meetings.
• Responsible for conducting shop floor walkthroughs, observations, and troubleshooting as they investigate or support applicable deviations.

Knowledge/Skill:
• Knowledge and understanding of FDA regulations, in particular the section of cGMPs, as well as Bristol-Myers Squibb policies and procedures.
• Extensive knowledge of working in a regulated environment and the importance of following procedures, cGMPs and EHS and the skillset to work and manage within a regulated environment
• The position requires ability to work independently, strong attention to detail, ability to drive performance and meet metric commitments and ability to make informed decisions
• Previous experience in providing sound justification and explanation to representatives from health authorities / regulatory agencies is highly desired.
• Knowledge of electronic systems including: SAP, LIMS, TrackWise, and Microsoft Office Suite is highly desirable.
• Previous work responsibility, which required a high degree of attention to detail
• Ability to work independently and make sound judgments in assuring compliance with regulations under tight timelines.
• Demonstrate excellent organizational skills and ability to effectively prioritize work
• Effective interaction with all contacts and the ability to work in a team based environment and interact well with other employees at various levels.
• Must be flexible and capable of handling several high priority items simultaneously on an ongoing basis.

Education/Experience/ Licenses/Certifications:
• Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is highly desired.
• Minimum of 4 years direct biologics Manufacturing, Quality Assurance, or Quality Control experience
• Experience working directly with assurance of product quality is highly desired