Quality Engineering Specialist

USWM, LLC•Louisville, KY

About The Position

SUMMARY: US WorldMeds is seeking a Quality Engineering Specialist to provide Quality oversight on product, process, equipment, software, and facilities changes while ensuring the validation and qualification activities are consistent with regulations and USWM’s validation practices and procedures. The Specialist assists with defining qualification & validation strategies and to ensure the necessary documents (i.e. plans, protocols, and reports) to satisfy both internal and external standards are generated appropriately. DUTIES AND RESPONSIBILITIES: The following reflects management’s definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation or other reasons.

Requirements

Bachelor’s Degree in Science or related technical field.
Minimum of 5+ years of Quality Assurance/Validation experience in the biotechnology or pharmaceutical industries.
Must demonstrate understanding of cGMP’s, industry and regulatory guidance, and multinational biopharmaceutical/cell therapy regulations.
Strong understanding of QA principles, industry practices, and standards with demonstrated ability to apply these to GMP operations is required.
Strong knowledge of global regulatory requirements for Clinical and Commercial GMP computerized systems validation, including current GAMP, ASTM-E2500, ICH guidelines and USP, 21CFR210, 21CFR211, and 21CFR11.
Knowledge of Quality Risk Management principles and experience with performing risk assessments using a variety of tools, i.e. FMEA.
Must be able to work well on cross-functional teams, as well as perform independently. Strong organizational skills are required and must be able to prioritize multiple tasks.
Must possess strong verbal/written communication skills and ability to influence at all levels.
Experience utilizing quality systems to support Quality Engineering activities (Document management, Training, Deviation management, Change Control management, and CAPA).
Ability to think strategically and to translate strategy into actions
Must be able to prioritize multiple tasks and ensure completion in a timely manner while working within a fast-paced environment.
Ability to provide clear direction to team members in a highly dynamic environment
Candidate must be proficient in Microsoft Word, Excel, PowerPoint.

Nice To Haves

Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies.
Deep knowledge of facility/clean room design, process, equipment, automation, and validation
Experience with Calibration manager databases, Electronic Lab Notebooks, Veeva, Validation Data Acquisition systems (ie Kaye, Ellab, Temp Tale), Building Management systems, Document Control Software
Experience with leading the start-up, validation, and licensure of manufacturing facilities.
Strong knowledge and direct experience with aseptic manufacturing and the validation of aseptic processes (aseptic process validation).
Experience working with cell and gene therapies or biologics products.
Experience working with external parties and/or leading cross-functional teams

Responsibilities

Responsible for QA review and approval of all validation records and documentation (i.e. process validation, computer system validation, and equipment lifecycle documentation including but not limited to URS, DQ, FAT, SAT, IQ, OQ, PQ, and PV protocols and reports)
Assist in the monitoring of quarterly reports, periodic reviews and/or revalidation of equipment and processes
Review and approve protocol discrepancies related to manufacturing process equipment, utilities, computer systems, validation, and laboratory instruments.
Ensure GMP compliance in all areas of validation/qualification and that systems are fully validated/qualified and all documentation completed before they are released for GMP use.
Liaise with key personnel within project teams to ensure validation tasks are completed in a timely manner.
Collaborate on the Aseptic Process Validation strategies, assessments and protocols to ensure the Navy Yard manufacturing facility remains compliant.
Responsible for performing change control assessments and reviewing/approving change control implementation plans for process, equipment, utilities, and computer system validation.
Maintain inspection readiness and actively support regulatory inspections, internal or external audits and assist in the preparation of information requested by regulatory agencies or internal/external auditors.
Participate in routine plant operating meetings (CAPA, Deviation, Change Control) and serve as Quality Engineering SME.
Ensure that work is performed in accordance with applicable regulations, cGMPs, industry guidelines and practices, and Adaptimmune policies and procedures.
Participate in efforts to identify opportunities for and to implement continuous improvement and optimization of practices related to validation.