Quality Control Specialist II, Operations Strategy

Seeking a Specialist II, Quality Control, Operations Strategy, who will support the long-term sustainability of the Lean Labs initiative within the Quality Control Department.? This role will be responsible for planning and managing projects with some oversight, utilizing principles and methodologies from Lean, Six Sigma, and Project Management to drive continuous improvement for all QC functional areas, and the creation and maintenance of QC workforce models to ensure patient demand is met. ?In addition, this role will support strategic planning for the implementation of pipeline products and projects in the QC department. This position is also responsible for maintaining knowledge of lean labs principles and various operational excellence strategies within the department by providing lean focused leadership, training, coaching, and mentorship to QC personnel.? The Specialist II, Quality Control, Operations Strategy must have experience with lean labs, different operational excellence concepts, tier governance, workforce modeling and planning, and be a highly collaborative team player who is able to work on continuous improvement in dynamic environments.

Essential Functions and Responsibilities

• Collaborate closely with the Senior Manager, Quality Control, Operations Strategy as well as other QC functions to strategically plan future projects such as new product introduction, laboratory capacity planning, facility transfers and expansions, and other pipeline projects.
• Develop and upkeep planning tools to allow for site growth within the quality control organization such as headcount capacity models for increased manufacturing capabilities and onboarding of new quality control assays, tests, and processes that contribute to the release of lots and materials.
• Facilitate the deployment, hypercare, change management, and maintenance of new and ongoing lean labs implementation in Quality Control.
• Collect and analyze data from QC workforce models to allow for opportunity identification, solution development, and sustainability.
• Monitor and routinely evaluate KPIs, metrics, heat maps, and A3s to measure performance of quality functional areas.
• Act as subject matter expert to QC’s lean capabilities by facilitating training and coaching of problem solving using the lean tool kit.
• Collaborate with other continuous improvement professionals to cascade needs and projects throughout the business and achieve solutions that drive positive business results.
• Provide support to Senior Quality Control Specialists with leading and developing effective and efficient management systems for the Quality Control Organization
• Must adhere to core values, policies, procedures, and business ethics.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Perform miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent) with a minimum of 5 years of experience in the biopharmaceutical industry within a cGMP Quality Control role, or a master’s degree with 3 years of relevant experience
• At least one year of experience working with/implementing different operational excellence concepts including (but not limited to) lean labs, lean practitioner, tier governance, coaching kata, gemba walks, job instruction, Kaizen, A3 problem solving, change management, leader standard work.
• Fundamental knowledge of Quality Control operational and laboratory practices including, but not limited to, microbiology, analytical testing, sample management, quality records, and training.
• Advanced proficiency in MS Office (Word, Excel, Powerpoint, Visio)
• Successfully interface with multi-disciplined teams
• Extremely detail-oriented with strong written, and verbal communication skills
• Ability to effectively balance multiple priorities involving aggressive timelines at a high level of productivity
• Advanced strategic planning and implementation
• Demonstrate sense of urgency; ability to recognize time sensitivity
• Flexible and adaptable style with an eagerness to take on challenges
• Problem solver who not only identifies issues but leads efforts to resolve them