Quality Assurance Analyst, Operational Strategy

2 weeks ago

Philadelphia, Pennsylvania, United States Planet Pharma Full time

CONTRACT-TO-HIRE

ESSENTIAL QUALIFICATIONS:

  • Bachelor's degree in a relevant field (biological sciences or equivalent) with over 3 years of experience in the biopharmaceutical sector within a cGMP Quality Control capacity
  • Proficient in various operational excellence methodologies including lean labs, lean practitioner, tier governance, coaching kata, gemba walks, job instruction, Kaizen, A3 problem solving, change management, and leader standard work
  • Comprehensive understanding of Quality Control operational and laboratory protocols including microbiology, analytical testing, sample management, quality documentation, and training

Position Overview:

We are looking for a Quality Control Coordinator, Process Improvement who will contribute to the ongoing success of the Lean Labs initiative within Planet Pharma. This role will play a key part in identifying and implementing continuous enhancements in collaboration with QC functional areas, as well as the development and maintenance of QC workforce models to ensure that patient needs are effectively met. Additionally, this position will aid in strategic planning for the rollout of pipeline products and projects within the QC department. The Quality Control Coordinator, Process Improvement must possess a solid background in lean labs, various operational excellence methodologies, workforce modeling, and planning, and be a highly collaborative team member who thrives in dynamic settings.

Key Responsibilities:

  • Work closely with the Senior Manager, Quality Control, Operational Strategy and other QC functions to strategically plan upcoming projects such as new product introductions, laboratory capacity assessments, facility relocations and expansions, and other pipeline initiatives.
  • Create and maintain planning tools to facilitate site growth within the quality control organization, including headcount capacity models for enhanced manufacturing capabilities and onboarding of new quality control assays, tests, and processes that support the release of lots and materials.
  • Assist with the deployment, hypercare, change management, and ongoing maintenance of lean labs implementation in Quality Control.
  • Maintain and update QC workforce models.
  • Regularly monitor and assess KPIs, metrics, heat maps, and A3s to evaluate the performance of quality functional areas.
  • Support the development of QC's lean capabilities by leading training and coaching sessions focused on problem-solving using the lean toolkit.
  • Collaborate with other continuous improvement professionals to communicate needs and projects throughout the organization and achieve solutions that yield positive business outcomes.
  • Adhere to core values, policies, procedures, and business ethics.
  • Comply with Safety SOPs, SDS sheets, and laboratory protocols as per company policy and OSHA regulations.
  • Perform other duties as assigned.

Required Qualifications:

  • Bachelor's degree in a relevant field (biological sciences or equivalent)
  • Minimum of 3 years of experience in the biopharmaceutical industry within a cGMP Quality Control role
  • Experience with various operational excellence methodologies 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.
  • Strong knowledge of Quality Control operational and laboratory practices including, but not limited to, microbiology, analytical testing, sample management, quality documentation, and training.
  • Advanced proficiency in MS Office (Word, Excel, PowerPoint, Visio)
  • Ability to effectively collaborate with multi-disciplinary teams
  • Detail-oriented with excellent written and verbal communication skills
  • Capacity to manage multiple priorities involving tight timelines while maintaining high productivity
  • Advanced strategic planning and implementation skills
  • Demonstrated sense of urgency; ability to recognize time-sensitive tasks
  • Flexible and adaptable approach with a willingness to tackle challenges
  • Proactive problem solver who not only identifies issues but also leads efforts to resolve them

Preferred Qualifications:

  • Experience with cell therapy products is an advantage.

  • Quality Assurance Analyst

    5 months ago

    Philadelphia, Pennsylvania, United States IT Excel LLC Full time

    Job Description The QA analysis job description encompasses two main roles testing and documentation. After software developers complete software programming quality assurance analysts test it. They use a variety of tools testing applications and reports to compare the software to user requirements. They ensure that the software functions according to those...

  • Quality Assurance Testing Lead

    7 days ago

    Philadelphia, Pennsylvania, United States Morgan Lewis Full time

    Morgan, Lewis & Bockius LLP is actively seeking an experienced Quality Assurance Test Manager to enhance their operations. This prestigious global law firm, recognized for its influence in major business and legal hubs, requires a professional dedicated to maintaining the highest standards of quality and dependability in their technological offerings.The...

  • Quality Assurance Testing Leader

    2 weeks ago

    Philadelphia, Pennsylvania, United States Morgan Lewis Full time

    Morgan, Lewis & Bockius LLP is seeking an experienced Quality Assurance Test Manager to enhance their operations. This prominent global law firm, recognized for its extensive influence in major business and legal hubs, requires a professional who can guarantee the exceptional quality and dependability of their technological solutions.The ideal candidate will...

  • Quality Assurance Testing Leader

    2 weeks ago

    Philadelphia, Pennsylvania, United States Morgan Lewis Full time

    Morgan, Lewis & Bockius LLP is seeking an experienced Quality Assurance Testing Leader to enhance their operational excellence. This prestigious global law firm, recognized for its influence in major business and legal hubs around the world, requires a professional dedicated to ensuring the highest standards of quality and dependability in their...

  • Quality Assurance Specialist in Operations Strategy

    1 week ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job OverviewSalary: CompetitiveCompany Overview:Iovance Biotherapeutics is a pioneering organization dedicated to the advancement and commercialization of innovative cancer immunotherapies. We are currently seeking a Quality Control Specialist focused on Operations Strategy to enhance the long-term viability of our Lean Labs initiative within the Quality...

  • Quality Assurance Specialist, Operations Strategy

    2 weeks ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job OverviewSalary:Company OverviewIovance Biotherapeutics is a dynamic, late-stage organization dedicated to the advancement and commercialization of innovative cancer immunotherapies. We are currently in search of a Quality Control Specialist focused on Operations Strategy, who will play a pivotal role in ensuring the long-term success of the Lean Labs...

  • Quality Assurance Specialist in Warehouse Operations

    2 weeks ago

    Philadelphia, Pennsylvania, United States Impilo Full time

    Job Overview: Quality Assurance SpecialistPosition SummaryThe Quality Assurance Specialist is tasked with ensuring compliance with established Standard Operating Procedures (SOPs), identifying potential risks and inaccuracies, and guaranteeing 100% precision in all outgoing shipments. This role is crucial in upholding and enhancing the quality benchmarks...

  • CPG Operations Strategy Analyst

    2 weeks ago

    Philadelphia, Pennsylvania, United States LA COLOMBE HOLDINGS GROUP Full time

    Job DetailsJob LocationLocated at PHL Fishtown Offices in Philadelphia, PennsylvaniaPosition TypeFull TimeJob CategorySalaryDescriptionCareer Opportunity:We are seeking a CPG Operations & Strategy Demand Planning Analyst to play a pivotal role in advancing our CPG initiatives. As a demand planning expert, you will collaborate with sales and marketing teams...

  • CPG Operations Strategy Analyst

    2 weeks ago

    Philadelphia, Pennsylvania, United States LA COLOMBE HOLDINGS GROUP Full time

    Job DetailsJob LocationLocated at PHL Fishtown Offices in Philadelphia, PennsylvaniaPosition TypeFull TimeJob CategorySalaryDescriptionCareer Opportunity:We are seeking a CPG Operations & Strategy Demand Planning Analyst to play a pivotal role in enhancing our CPG business growth. As a specialist in demand forecasting, you will collaborate with sales and...

  • Lead Quality Assurance Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States EPM Scientific Full time

    Position: Lead Quality Assurance SpecialistCompany: EPM ScientificA prominent player in the pharmaceutical sector is seeking a qualified individual with a robust background in Quality Assurance to enhance their team as a Lead Quality Assurance Specialist.Key ResponsibilitiesDesign and execute Quality Assurance frameworks and protocols.Perform audits and...

  • Quality Assurance Analyst

    2 months ago

    Philadelphia, Pennsylvania, United States The University of Pennsylvania Full time

    The Quality Assurance Analysis will work within the Clinical Cell and Vaccine Production Facility (CVPF) for the review and release of investigational cell and gene therapy products for human administration manufactured at our facility.Communicate errors and deviations identified during batch record review.Conduct apheresis product receipt of fresh and...

  • Head of Quality Assurance

    1 week ago

    Philadelphia, Pennsylvania, United States Adaptimmune Full time

    Head of Quality Assurance at AdaptimmuneAdaptimmune is a comprehensive cell therapy organization, prominently positioned in both the U.K. and U.S., alongside various biotechnology hubs.Our core values emphasize trust, teamwork, and integrity as we strive to enhance the lives of individuals battling cancer.Key Responsibilities:Ensure that team members receive...

  • Quality Assurance Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States Leonardo Full time

    Position Overview:The Quality Assurance Specialist plays a crucial role in ensuring compliance with Quality Management System (QMS) standards. This position is responsible for interpreting quality requirements, ensuring adherence to both organizational and regulatory standards, and participating in various reviews to guarantee that quality attributes are...

  • Consumer Goods Strategy Analyst

    2 weeks ago

    Philadelphia, Pennsylvania, United States LA COLOMBE HOLDINGS GROUP Full time

    Position: CPG Operations & Strategy, Demand Planning AnalystThis full-time role within the Consumer Packaged Goods (CPG) sector presents a unique opportunity for a Demand Planning Analyst.OBJECTIVE: Serve as a demand planning authority for the CPG division by working closely with sales and marketing teams to generate precise forecasts and recommending...

  • Quality Assurance Certification Specialist

    7 days ago

    Philadelphia, Pennsylvania, United States Jobot Full time

    About the Company:This organization is a prominent player in the financial technology sector, recognized for its consistent growth and profitability. They offer an exceptional compensation package that reflects their commitment to employee satisfaction.Position Overview:This role is focused on enhancing the quality assurance and certification processes for...

  • Consumer Goods Strategy Analyst

    2 weeks ago

    Philadelphia, Pennsylvania, United States LA COLOMBE HOLDINGS GROUP Full time

    Position: CPG Operations & Strategy, Demand Planning AnalystThis full-time role within the Consumer Packaged Goods (CPG) sector presents a unique opportunity for a Demand Planning Analyst.OBJECTIVE: Act as a demand planning authority for the CPG division by working closely with sales and marketing departments to generate precise forecasts and suggesting...

  • Quality Assurance Supervisor

    7 days ago

    Philadelphia, Pennsylvania, United States WuXi AppTec Full time

    Job OverviewWuXi Advanced Therapies stands at the forefront of the global cell and gene therapy landscape, functioning as a premier contract testing, development, and manufacturing organization (CTDMO). Our commitment to innovation, excellence, and collaboration drives our mission to expedite the development and accessibility of life-saving therapies for...

  • Quality Assurance Automation Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States JobRialto Full time

    Position Overview:As a Quality Assurance Automation Specialist, you will play a pivotal role in ensuring the excellence of our software products at JobRialto. Your technical expertise will be essential in enhancing our testing processes and delivering high-quality applications.Key Responsibilities:1. **Project Management:** - Establish project milestones...

  • Technical Operations Specialist

    2 days ago

    Philadelphia, Pennsylvania, United States PCI Pharma Services Full time

    Job SummaryWe are seeking a highly skilled Technical Operations Specialist to join our Quality Assurance team at PCI Pharma Services. As a Technical Operations Specialist, you will be responsible for performing release testing on finished good products, ensuring they meet predetermined specifications and regulatory requirements.Key ResponsibilitiesPerform...

  • Quality Assurance Automation Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States JobRialto Full time

    Position Overview:As a Quality Assurance Automation Specialist at JobRialto, you will play a pivotal role in ensuring the excellence of our software products. Your technical expertise will be essential in developing automated testing solutions and enhancing our quality assurance processes.Key Responsibilities:1. **Project Management:**Establish project...