Job Description

618013 Senior Quality Control Specialist, QC Operations Strategy

Direct Hire

Philadelphia, PA

Overview

Senior Quality Control Specialist, QC Operations Strategy will be responsible for planning and managing projects with minimal 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. T This role is responsible for identifying and driving continuous improvement in collaboration with QC functional areas, and the creation and maintenance of the QC workforce models to ensure patient demand is met. 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 Senior Quality Control Specialist, QC 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 works well in dynamic environments.

Essential Functions and Responsibilities

• Drive deployment, hypercare, change management, and maintenance of ongoing lean labs implementation in Quality Control.
• Build and maintain QC workforce models.
• Utilize SME knowledge of lean methodologies to collaborate with QC leadership to define strategy, plan, and oversee the execution of key initiatives that deliver significant business value.
• Collaborate with other continuous improvement professionals to cascade needs and projects throughout the business and achieve solutions that drive positive business results.
• 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.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Must adhere to company’s core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
• Minimum (5) years of experience in the biopharmaceutical industry within a cGMP Quality Control role
• Experience with different operational excellence concepts including (but not limited to) lean labs, lean practioner, 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 in a global setting
• Extremely detail-oriented with strong written, and verbal communication skills
• Ability to effectively manage 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

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

· Must be able to remain in a stationary position standing or sitting for prolonged periods of time.

· Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.

· Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.

· This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.

· Must be able to communicate with others to exchange information.

Mental : Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

Work Environment

This job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible. Requires operating standard office equipment and keyboards.

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

We are committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law

***Pay rate is commensurate with experience. Target pay rate range is $95-110K***

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