- The Sr. Quality Specialist - Technical Operations will have Quality Assurance functions 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.
- 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 efforts. 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 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 required
- Working knowledge of standard industry IT solutions (i.e. LIMS, SAP, Trackwise) is preferred.
- Problem-solving and decision-making skills, and the ability to prioritize and successfully manage complex and competing projects is required
- Minimum 5 years' experience in the pharma/biotech industry
- Demonstrated expertise in equipment/utility Validation, Change Control, Deviations, CAPAs, and document generation and review
- Direct experience with SIP (Steam in process) and Autoclave qualification
- Proficiency in facilitating cross-functional meetings with senior staff members and functional area leads
- Thermo mapping, temperature control
- Clean room
Please submit your resume for consideration. Once submitted, feel free to contact Michael at 347-522-1095 for additional information.
Approx. Duration: 6+ months
About Hired By Matrix
Hired by Matrix, Inc. founded in 1986, is a certified Woman-Owned Business Enterprise (WBE) dedicated to providing the highest quality of job opportunities to our candidates and staffing services to our clients. We are a full service staffing firm with experience recruiting and delivering for IT, Accounting & Finance, Administrative & Clerical, Clinical & Scientific, and Marketing disciplines. Our long history in the staffing industry and dedication to excellence are the key differentiators that have fueled our success for over 30 years.
Hired by Matrix offers our contract professionals competitive salaries, benefits after 60 days and a 401k option after one year.
Equal Opportunity Employer
*CEO Sharon Olzerowicz serves on the WBENC Board and is a long-standing member of the Forum Governing Group.
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