Quality Engineering Specialist

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.

* 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.

QUALIFICATIONS:

Preferred

* 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).

* 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

* 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.

Desirable

* 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

COMPETENCIES:

* Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.

* Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.

* Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.

* Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.

* Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.

* Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.

* Business Acumen - Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals.

* Cost Consciousness - Works within approved budget; Develops and implements cost saving measures; Contributes to profits and revenue; Conserves organizational resources.

* Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

* Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.

* Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.

* Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.

* Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.

* Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

* Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly. The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

PHYSICAL DEMANDS:

* Frequently required to stand

* Frequently required to walk.

* Frequently required to sit.

* Frequently required to talk or hear.

* Occasionally required to lift light weights (less than 25 pounds)

* Specific vision abilities required for this job include: close vision, color vision and

ability to adjust or focus

WORK ENVIRONMENT:

* The noise level in the work environment usually is quiet