The Sr. Quality Specialist – Technical Operations will have Quality Assurance functions
within the Pilot Plant, to ensure adherence with cGMPs, EMEA, ICH and JP
regulations. This individual will provide quality assurance support of validation,
manufacturing, and testing of clinical trials materials. This individual will also serve as a
quality assurance resource for the Pilot Plant staff, and will help to guide and advise on
activities for the staff.
Responsibilities Percent of Time
1. Provide QA support within the Pilot Plant in the execution of key
quality systems, including: equipment, system, and utility
validation, SIP, Autoclave, and ongoing process improvement
2. Provide quality support to processes such as (but not limited to)
batch release, deviation and CAPA management, facility
management/maintenance processes, Validation, and change
3. Creation/Maintenance of Policies/Procedures, as needed 25%
4. Provide review of technical, validation and other protocols and
reports, with emphasis on adherence to quality systems, and
with FDA, EMEA, ICH and JP regulations/guidance.
This position will maintain Quality systems, while ensuring seamless and efficient efforts
are applied to ongoing validation, maintenance, automation, and change management
processes while ensuring compliance with established policies and procedures
Bachelor-level degree in quality and/or biological sciences or related subjects is
required; Graduate level degree preferred.
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.
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.).
Experience with equipment and facility deviation, and change management is
Working knowledge of standard industry IT solutions (i.e. LIMS, SAP, Trackwise) is
Problem-solving and decision-making skills, and the ability to prioritize and
successfully manage complex and competing projects is required
1) Minimum 5 years' experience in the pharma/biotech industry
2) Demonstrated expertise in equipment/utility Validation, Change Control, Deviations, CAPAs, and document generation and review
3) Direct experience with SIP (Steam in process)and Autoclave qualification
4) Proficiency in facilitating cross-functional meetings with senior staff members and functional area leads
5) Thermo mapping, temperature control
6) Clean room
Source: Job Diva – Job Listing