Description:
The Sr. Quality Specialist - Technical Operations will have Quality Assurance functions within the Biologics Pilot Plant, to ensure adherence with cGMPs, EMEA, ICH and JP regulations.
This individual will provide quality assurance support for equipment, systems, utilities, and sterilization processes throughout their respective lifecycles. This includes quality oversight for validation, automation, and facilities (maintenance / metrology) functional areas to support clinical and commercial production activities.
The Sr. Quality Specialist will routinely interface with TrackWise for compliance record-related activities, as well as a Computerized Maintenance Management System for interactions with asset management records.
Responsibilities Percent of Time
Provide quality support for Validation documentation and processes within the Pilot Plant. This includes, but is not limited to, review and approval of testing documentation, reports, and applicable lifecycle documents.
Provide quality support for Facilities and Automation documentation and processes within the Pilot Plant. This includes, but is not limited to, review and approval of CMMS forms, electronic work orders, out of tolerance calibration investigations, and engineering change requests.
Provide quality support for compliance record management for the Pilot Plant utilizing TrackWise. This includes, but is not limited to, review, approval, trending, and metrics for deviations, CAPAs, commitments, effectiveness checks, change controls, and implementation activities.
Assess system and product impact in response to critical alarms, and determine if fitness for use was affected.
Creation/maintenance of written procedures, as needed.
Participating in and facilitation of meetings and discussions, as needed.
• Bachelor-level degree in quality and/or biological sciences or related subject is required; Graduate level degree preferred.
• Position requires at least 5 years performing standard Quality Assurance functions (for example; SOP and protocol writing, design document and drawing review, quality specifications development, batch release functions, training, auditing, etc.).
• Must have knowledge of FDA, EMEA and JP regulations as they pertain to building design, process requirements and development of antibody-based bio therapeutics.
• Experience working in a GMP environment is required; experience working in a biologics Pilot Plant facility is preferred.
• Experience with equipment/utility/SIP/Autoclave Validation is required.
• Experience with equipment and facility deviation, and change management is required
• Working knowledge of Trackwise and CMMS is required.
Problem-solving and decision-making skills, and the ability to prioritize and successfully manage complex and competing projects is required
MUST HAVES
1) Validation experience
2) Temperature mapping experience using thermocouples, this includes:
a. Steam-in-Place Validation
b. Autoclave Validation
c. Controlled Temperature Unit (CTU) Validation
3) TrackWise experience
4) Good investigation skills
5) Good technical writing skills