Senior Quality Control Specialist, LIMS

3 weeks ago

Philadelphia, United States Planet Pharma Full time

615725 Senior Quality Control Specialist, LIMS

Direct Hire

Philadelphia, PA

Shift: M-F, 8am-5pm


Overview

The Senior Quality Control Specialist, LIMS role is responsible for deployment and administration of the QC Laboratory Information Management System (LIMS). This role represents QC in the development, configuration, validation, implementation and maintenance of the LIMS as it relates to QC functionality including analytical and microbiology testing, environmental monitoring, raw materials, critical reagents, stability and sample management to support compliance with regulatory requirements and commitments for clinical and commercial products.

This individual has a good understanding of, and experience with LIMS within a cGMP-regulated environment. The position reports to the Director, Quality Control Compliance.

Essential Functions and Responsibilities

  • Understand and execute change management in a GMP environment and drive changes through appropriate quality system. Own changes, as required.
  • Support deviations and LIR’s with LIMS information, as needed.
  • Collaborate with stakeholders to develop the requirements and the long-term vision for LIMS.
  • Drive development and implementation of the LIMS by partnering with IT and external vendors.
  • Develop and regularly update key project information such as status, timelines, scope statements, budgets, resources, risks, issues, decisions, and action items.
  • Manage enhancements, incident investigation, and changes for a multi-site, global LIMS
  • Draft program related support documents including operational SOPs, Work Instructions, System Impact assessments, change controls, as needed.
  • Track and resolve LIMS support program issues and identify potential enhancements to the system.
  • Independently plan, manage and execute assignments, contribute to project planning meetings.
  • Support product stability programs including generation of stability protocols in LIMS, and support as needed accessing final reporting or trending of stability data
  • All duties are performed with minimal supervision and oversight
  • 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, computer science or equivalent)
  • Minimum of 5-10 years of experience in a cGMP laboratory including at least 3 years as a LIMS administrator. Experience with configuring and implementing a LIMS
  • Experience with translating business documents (batch records, test methods, stability protocols) into technical requirements and configuring in a LIMS solution.
  • Ability to manage external partners with respect to technical support activities
  • Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines.
  • Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based on changing priorities.
  • Problem solver who not only identifies issues but leads efforts to resolve them

Preferred Education, Skills, and Knowledge

  • Experience with cell and/or gene therapy products is a plus.
  • Experience with MS SQL Server or Oracle database 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 accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.

Physical Demands and Activities Required:

  • Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
  • Must meet requirements for and be able to wear a half-face respirator.
  • Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps.
  • Must be able to use near vision to view samples at close range
  • Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
  • Must be able to lift and carry objects weighing 45 pounds.

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 both an office and a manufacturing lab setting.
  • 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.

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 is $120-135K***

  • Senior Quality Control Specialist, LIMS

    4 weeks ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics, Inc. Full time

    Job Summary:The Senior Quality Control Specialist, LIMS will be responsible for the deployment and administration of the Quality Control Laboratory Information Management System (LIMS). This role represents Quality Control in the development, configuration, validation, implementation, and maintenance of the LIMS as it relates to Quality Control...

  • Senior Quality Control Specialist, LIMS

    2 weeks ago

    philadelphia, United States Planet Pharma Full time

    615725 Senior Quality Control Specialist, LIMS Direct HirePhiladelphia, PAShift: M-F, 8am-5pmOverview The Senior Quality Control Specialist, LIMS role is responsible for deployment and administration of the QC Laboratory Information Management System (LIMS). This role represents QC in the development, configuration, validation, implementation and maintenance...

  • Senior Quality Control Specialist, LIMS

    3 weeks ago

    philadelphia, United States Planet Pharma Full time

    615725 Senior Quality Control Specialist, LIMS Direct HirePhiladelphia, PAShift: M-F, 8am-5pmOverview The Senior Quality Control Specialist, LIMS role is responsible for deployment and administration of the QC Laboratory Information Management System (LIMS). This role represents QC in the development, configuration, validation, implementation and maintenance...

  • Senior Quality Control Specialist, LIMS

    1 month ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job DescriptionIovance Biotherapeutics Inc is hosting an onsite Job Fair to connect with talented professionals.Event DetailsLocation: Iovance Cell Therapy Center (iCTC)Address: 300 Rouse Blvd, Philadelphia, PA 19112Date: Wednesday, October 23, 2024Time: 12pm to 6pm (EDT)What to ExpectMeet our team and learn about our company culture, benefits, and career...

  • Senior Quality Control Specialist, LIMS

    3 weeks ago

    Philadelphia, United States Planet Pharma Full time

    OverviewThe Senior Quality Control Specialist, LIMS role is responsible for deployment and administration of the QC Laboratory Information Management System (LIMS). This role represents QC in the development, configuration, validation, implementation and maintenance of the LIMS as it relates to QC functionality including analytical and microbiology testing,...

  • Senior Quality Control Specialist

    3 weeks ago

    Philadelphia, United States Planet Pharma Full time

    Senior Quality Control Specialist needed!The Senior Quality Control Specialist, LIMS role is responsible for deployment and administration of the QC Laboratory Information Management System (LIMS). This role represents QC in the development, configuration, validation, implementation and maintenance of the LIMS as it relates to QC functionality including...

  • Project Manager, IT Specialist/LIMS

    1 month ago

    Philadelphia, United States Actalent Full time

    Job DescriptionJob DescriptionProject Manager, IT Specialist/LIMSPosition Overview:The Project Manager, IT Specialist LIMS will play a crucial role in ensuring the successful execution of IT projects related to Laboratory Information Management Systems (LIMS), Regulatory Information Management Systems (RIMS), and biostatistics analysis systems. This role...

  • Quality Control Specialist

    4 weeks ago

    Philadelphia, Pennsylvania, United States bioMerieux, Inc Full time

    Job Summary:As a Quality Control Specialist at bioMerieux, Inc, you will play a critical role in ensuring the quality of our products. Your primary responsibility will be to conduct quality control testing on finished products, prepare reports, and submit them for review to the Quality Manager for release. You will also perform a wide variety of inspection,...

  • Lead Quality Control Specialist, Sample Management

    1 month ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job SummaryThe Lead Quality Control Specialist, Sample Management is responsible for overseeing the management of sample inventory and distribution, ensuring compliance with procedures, specifications, and cGMP. This role requires strong organizational and communication skills, as well as the ability to work in a fast-paced environment.Key...

  • Senior Quality Assurance Specialist

    4 weeks ago

    Philadelphia, Pennsylvania, United States Meet Full time

    Job Title: Senior Quality Assurance SpecialistJob Summary:We are seeking a highly skilled Senior Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will play a critical role in ensuring the quality and compliance of our products throughout the development and manufacturing processes.Key Responsibilities:Quality...

  • Quality Control Specialist

    1 month ago

    Philadelphia, Pennsylvania, United States Jobot Full time

    Job SummaryWe are seeking a highly skilled Quality Control Specialist to join our team at Jobot. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality in our pharmaceutical products.Key Responsibilities:Gather and review data from chemists in accordance with internal Standard Operating Procedures...

  • Quality Control Specialist

    3 weeks ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    Job SummaryPlanet Pharma is seeking a Quality Control Specialist to support quality control testing operations in our laboratory.This role requires hands-on experience in cell culture, ELISA, and flow cytometry, as well as a solid understanding of GMP regulations and technical writing skills.ResponsibilitiesPerform daily GMP quality control laboratory...

  • Refractory Quality Assurance Specialist

    1 month ago

    Philadelphia, Pennsylvania, United States Hwi Full time

    Job SummaryThe Facility Quality Assurance Technician plays a crucial role in supporting HWI's mission to drive industry performance and deliver quality results. This position focuses on the actual testing of products and raw materials, ensuring they meet standards and accurately entering data into our Laboratory Information Management System (LIMS).A...

  • Quality Control Specialist Operations Strategy

    4 weeks ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics, Inc. Full time

    Job SummaryIovance Biotherapeutics, Inc. is seeking a highly skilled Quality Control Specialist Operations Strategy to support the long-term sustainability of the Lean Labs initiative within the Quality Control Department. This role will assist with identifying and driving continuous improvement in collaboration with QC functional areas, and the creation and...

  • Quality Control Specialist Operations Strategy

    4 weeks ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics, Inc. Full time

    Job SummaryWe are seeking a highly skilled Quality Control Specialist, Operations Strategy to support the long-term sustainability of the Lean Labs initiative within the Iovance Quality Control Department.Key ResponsibilitiesCollaborate closely with the Senior Manager, Quality Control, Operations Strategy and other QC functions to strategically plan future...

  • Quality Assurance Specialist Senior

    4 weeks ago

    Philadelphia, Pennsylvania, United States Adaptimmune Full time

    Job Title: Quality Assurance Specialist SeniorJob Summary:Adaptimmune is seeking a Quality Assurance Specialist Senior to provide quality oversight on product, process, equipment, software, and facilities changes while ensuring the validation and qualification activities are consistent with regulations and Adaptimmune's validation practices and...

  • Quality Control Training Specialist

    4 weeks ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job SummaryIovance Biotherapeutics Inc is seeking a highly skilled Quality Control Training Specialist to support quality control training at our integrated Cell Therapy Center (iCTC). The successful candidate will have hands-on laboratory training experience in cell culture, cell-based potency assays, and multicolor flow cytometry platforms.The Quality...

  • Quality Control Specialist

    1 month ago

    Philadelphia, Pennsylvania, United States Precision Group Inc Full time

    Job Summary:The Quality Control Specialist will be responsible for ensuring that our clients' reciprocating compressors are built, refurbished, and installed correctly and to the appropriate standards. This role requires a strong understanding of manufacturing methods and procedures, as well as quality management and measurement.Key Responsibilities: Conduct...

  • Senior Quality Assurance Specialist, Investigations

    1 week ago

    Philadelphia, United States Planet Pharma Full time

    $115,000/year - $120,000/year 10% Bonus Long Term Incentives OverviewThe Senior Quality Assurance Specialist, Operations Investigations role will support review of deviations, investigations, protocols to support release of materials and products. The Sr. Quality Operations Investigations Specialist will also ensure compliance to company procedures by...

  • Quality Assurance Document Control Specialist

    4 weeks ago

    Philadelphia, Pennsylvania, United States Catalent Inc Full time

    Job Title: Quality Assurance Document Control SpecialistCatalent Inc is seeking a Quality Assurance Document Control Specialist to join our team. As a Quality Assurance Document Control Specialist, you will be responsible for preparing customer files, reviewing and approving batch records, and releasing batch records and finished product.Key...