Location - Greater Philadelphia Area
The Sr. Quality Specialist - Technical Operations will have Quality Assurance functions
within the Pilot Plant, to ensure adherence with cGMPs, EMEA, ICH and JP
- This individual will provide quality assurance support of validation, manufacturing, and testing of clinical trials materials. This individual will also serve as aquality assurance resource for the Pilot Plant staff, and will help to guide and advise onactivities for the staff.
- Responsibilities Percent of Time:
- Provide QA support within the Pilot Plant in the execution of key quality systems, including: equipment, system, and utilityvalidation, SIP, Autoclave, and ongoing process improvementefforts - 25%
- Provide quality support to processes such as (but not limited to) batch release, deviation and CAPA management, facility management/maintenance processes, Validation, and change management - 25%
- Creation/Maintenance of Policies/Procedures, as needed 25%
- 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. - 25%
- 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 required.
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
7) Pilot Plant experience
If you're interested in this or a similar opportunity, your CV can be sent in MS Word to ...@vivosps.com
Associated topics: bacteria, biomedical, cytometry, drug discovery, food scientist, immunoassay, industrial hygienist, microbiology, nutrition, therapy
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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