Summary/Objective The Senior Quality Assurance Specialistis responsible for the effective, efficient, compliant and proactive management of new product launches and sustaining existing products. Senior level roles are considered subject matter experts and have the additional responsibility to coach and mentor additional team members in enhancing their technical knowledge and application of skill. Senior level positions also have the expectation of developing and enhancing their own coaching, mentoring, and soft (human) skills to fulfill their roles. Essential Functions - Uses quality tools to track and trend products and processes to internal and external metrics, regulatory standards and implement improvements.
- Performs quality reviews and internal audits; evaluates data and writes reports to validate or indicate deviations from existing standards.
- Lead and/or support Internal and External Audits.
- Support training management for quality and operations personnel.
- Acts as a customer liaison and processes customer quality complaints.
- Lead and manage quality involvement for the development of new products or sustaining products via validation methodologies such as TMV, equipment, process and product.
- Support DMF submissions and IND submissions with the regulatory bodies and customers as needed.
- Assist the development of essential QS deliverables including, but not limited to complaint analysis, risk analysis, failure mode and effects analysis, nonconformances, CAPA, Complaints and process/equipment/software verification/validation.
- Lead or guide team on NCMR, Complaints and CAPA.
- Work with production to document current process parameters and develop written instructions to eliminate unnecessary process variations and improve productivity.
- Participates in pre- and post-production reviews and approvals providing quality and regulatory support.
- Works with cross-functional teams to solve production and quality problems.
- Lead quality and compliance by complying with all Quality Systems documentation requirements and establishing/supporting plan(s) to meet/exceed Niowave goals for Quality that support Safety, Compliance, Six Sigma Quality, On-Time Delivery (OTD) and financial objectives.
- Lead and develop team members to develop our best team. Ensure the growth of our positive business culture through behaviors that align with our values and leadership competencies.
Competencies - Analytical and problem-solving skills; excellent interpersonal, written, and oral communication skills; Organizational and project management skills for self and teams.
- Models the Niowave Values of Teamwork, Courage, Integrity, and Upright Zeal.
- Understands how to integrate into a new team/organization - appreciates the history of current state, know how and when to make suggestions, as well as using just the right pace to reach the improved future state.
- Understands their own communication and learning styles, can assess others' styles, and is able to find the right path to connect the two.
- Knowledge of 21 CFR Part 211/212 and ICH Q7-Q12 is preferred
- Ability to apply logic and reasoning to solve complex problems, including identifying strengths/weaknesses, locating alternative solutions and conclusions, and approaches to problems; and making high-quality, timely decisions.
- Knowledge of quality management methods, tools, and techniques used to create and support an environment that meets the needs of the organization. Utilizes process flowcharting, Pareto analysis, correlation and regression analysis, significance tests, design of experiments, statistical process control, test method validation, and trend analysis techniques.
- Knowledge of pharmaceutical quality requirements for launching and sustaining new products, such as Lifecycle Management, Quality by Design or Technology Transfer.
- Knowledge and understanding of federal, state and local laws and regulations affecting manufacturing practices and activities.
- Experience with and working knowledge of cGMP and GLP quality systems.
- Knowledge of procedures and tools for scheduling and controlling production runs and assuring quality deliverables E.g., MRP, ERP systems.
Required Education and Experience - Bachelor's degree in Sciences or Engineering
- 5+ years of relevant quality system experience in pharmaceuticals.
Preferred Education and Experience Masters degree in Sciences or Engineering - Quality or Regulatory certifications are preferred (e.g., CQE, CQA, CQM, RAC)
- 8+ years of relevant quality system experience in pharmaceuticals.
- Hands-on experience utilizing lean manufacturing principles for continuous process improvements (Six Sigma, Lean Manufacturing, 5S)
- Experience operating in a cGMP CDMO or Finished Drug environment.
Physical Demands The position operates in a professional office and industrial environments which includes the use of standard office equipment and/or machinery related to the production of medical isotopes. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to (20 - 50) pounds. Position Type/Expected Hours of Work/Travel - Full-time position.
- Company's standard operating hours are Monday thru Friday 6a - 6p with production related activities requiring 24/7/365 shifts. This position will have regular working hours during M - F with an expectation of adjusting to work outside of the standards operating hours as needed.
- Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role.
Other duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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