Quality Control, Operations Strategy Specialist
3 weeks ago
609165 Specialist, Quality Control, Operations Strategy
Direct Hire
Philadelphia, PA
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.
- Assist with deployment, hypercare, change management, and maintenance of ongoing lean labs implementation in Quality Control.
- Maintain QC workforce models.
- Monitor and routinely evaluate KPIs, metrics, heat maps, and A3s to measure performance of quality functional areas.
- Assist with the development of 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.
- 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)
- Minimum (3) 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 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
Preferred Education, Skills, and Knowledge
- Experience with cell therapy products is a plus.
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 Sit for an extended amount of time in front of the computer.
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 deadline
Work Environment:
- This position will work in an office, with occasional visits to the Quality Control labs.
- When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
- Able to work in cleanroom with biohazards, human blood components, and chemicals.
- Potential exposure to noise and equipment hazards and strong odors.
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.
***Pay rate is commensurate with experience. Target pay rate range is $75-85K***
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