Quality Assurance Document Control Specialist II

2 months ago

Philadelphia, United States Iovance Biotherapeutics Inc Full time
Job DescriptionJob DescriptionSalary:

Overview

 

The Quality Assurance Document Control Specialist (QADC), Level II is a hybrid role providing support to Iovance facilities in Philadelphia, PA; Iovance’s Cell Therapy Center (iCTC) and Iovance facility within the American Red Cross building (IOVA-A). This position is responsible for supporting the Quality Document Control program and ensuring compliance to quality objectives and regulatory requirements. The individual must be qualified, highly motivated, detail oriented, and a team player.


Essential Functions and Responsibilities

 

  • Independently manage and monitor the processing, review, and approval of the archived documents in the Electronic Document Management System (eDMS).
  • Ensure compliance with controlled document format and content.
  • Manage the document periodic review process.
  • Provide user assistance and training on eDMS
  • Maintain master documents and records (both hardcopy and electronic) to ensure documentation is retrievable and files are accurate, complete, and well organized.
  • Responsible for managing record retention policies and procedures.
  • Assists with maintaining Quality Assurance Document Control tracking tools for metrics purposes.
  • Issuance of Patient and Non-Patient lot batch records to Manufacturing according to Master Production schedule.
  • Issuance of logbooks, protocols, and other controlled documents upon request.
  • Provides support for internal and regulatory audits and inspections as required.
  • Provides continuous feedback on improvements to Document Control processes.
  • Attends the meetings and escalates issues/concerns at that forum to Area Management for further investigation.
  • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
  • Perform miscellaneous duties as assigned.


Travel – none required


Preferred Education, Skills, and Knowledge

 

  • Bachelor’s degree in Life Sciences discipline preferred, but not required.
  • Two (2) to Five (5) years of QA document control experience in pharmaceutical or biopharmaceutical GMP based facility at minimum. 
  • Proficient in an eDMS system and document formatting.
  • Proficient in MS Office Suite and Archival skills. 
  • Must possess a high level of attention to details. 
  • Strong computer, organizational, and compliance skills. 
  • Familiarity with document change management and FDA quality systems. 
  • Ability to work effectively on multiple projects simultaneously with minimum supervision. 
  • Strong interpersonal and communication skills

 

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.
  • Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
  • Able to stand and/or walk in a 10-hr day which may include climbing ladders or steps.
  • Must be able to move about inside an office and exert up to 30 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
  • Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, safety glasses, etc.
  • 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.

 

Iovance is 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. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.

 

 By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice. 


#LI-Onsite

  • Quality Assurance Document Control Specialist

    1 month ago

    Philadelphia, United States Iovance Biotherapeutics Inc Full time

    Job DescriptionJob DescriptionSalary: Overview The Quality Assurance Document Control Specialist (QADC) I is located at Iovance’s Cell Therapy Center (iCTC) in Philadelphia PA. This position is responsible for supporting the Quality Document Control program at the iCTC facility and ensuring compliance to quality objectives and regulatory requirements. The...

  • Quality Control Specialist, Sterility Assurance

    3 weeks ago

    Philadelphia, United States Iovance Biotherapeutics Inc Full time

    Job DescriptionJob DescriptionSalary: OverviewThe Quality Control Specialist, Sterility Assurance is responsible for effectively collaborating with multiple stakeholders to ensure the harmonized execution of contamination control policies across the two manufacturing sites in Philadelphia. This role will also support new product transfers related to...

  • 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 Control Analytical Specialist

    7 days ago

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

    Position Overview The Analytical Sciences & Technology Specialist I is responsible for the technical advancement of quality assurance methodologies and processes, as well as the validation of methods and instruments. This role encompasses technical transfers associated with Analytical and/or Microbiological quality assurance testing of products, raw...

  • Quality Control Specialist II

    2 days ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job SummaryWe are seeking a highly skilled Quality Control Specialist II to join our team at Iovance Biotherapeutics Inc. The successful candidate will be responsible for supporting quality control testing operations at our Cell Therapy Center.Key ResponsibilitiesPerform daily cGMP quality control laboratory microbiological testing activities, including...

  • Quality Assurance Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States Bainbridge Health Full time

    Job OverviewPosition: Quality Assurance SpecialistCompany: Bainbridge HealthAbout Us: Bainbridge Health is dedicated to maximizing the potential of pharmacy data to improve the safety, efficiency, and reliability of medication management. Our mission is to empower pharmacy and safety leaders to avert patient harm, minimize unnecessary waste, and enable...

  • Quality Control Analytical Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job OverviewPosition Title: Analytical Sciences & Technology Specialist ISalary: CompetitiveRole Summary:The Analytical Sciences & Technology Specialist I is responsible for the technical advancement of quality assurance methodologies and processes, including the validation of methods and instruments, as well as the technical transfer related to Analytical...

  • Quality Control Analytical Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job OverviewPosition Title: Analytical Sciences & Technology Specialist ISalary: CompetitiveSummary:The Analytical Sciences & Technology Specialist I is responsible for the technical advancement of quality assurance methodologies and processes, including method and instrument validations, as well as technical transfers associated with Analytical and/or...

  • Quality Assurance Specialist

    2 days ago

    Philadelphia, Pennsylvania, United States Jobot Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Jobot. As a Quality Assurance Specialist, you will be responsible for investigating and resolving non-conformances and customer complaints in a timely and efficient manner.Key ResponsibilitiesCollaborate with cross-functional teams to initiate, investigate, document,...

  • Quality Control Analytical Specialist

    7 days ago

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

    Position Overview The Analytical Sciences & Technology Specialist I is responsible for the technical advancement of quality assurance methodologies and processes, validation of methods and instruments, and technical transfers pertinent to Analytical and/or Microbiological quality assurance testing of products, raw materials, and packaging components. This...

  • Quality Assurance Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States The Reserves Network Inc Full time

    Job OverviewWe are currently seeking a Quality Assurance Specialist to join our team. This role is essential in ensuring that our products meet the highest standards of quality and compliance.Key ResponsibilitiesConduct thorough in-process inspections and evaluate data for both CMM and floor inspections according to established control plans that fulfill...

  • Quality Control Analytical Specialist

    2 weeks ago

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

    Position Overview The Analytical Sciences & Technology Specialist I is responsible for the technical advancement of quality assurance methodologies and procedures, including method and instrument validations, as well as technical transfers related to Analytical and/or Microbiological quality control assessments of products, raw materials, and packaging...

  • Quality Assurance Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States MANN+HUMMEL Full time

    Position Overview This role is essential to our quality department and requires on-site presence. Working hours are from 3:00 PM to 11:00 PM, Monday through Friday. A shift differential of $1.00 per hour will be included in your compensation for the second shift. We are looking for local candidates. The Quality Assurance Specialist will engage in various...

  • Quality Assurance Specialist II

    4 weeks ago

    Philadelphia, United States Iovance Biotherapeutics Inc Full time

    Job DescriptionJob DescriptionSalary: Overview The Quality Assurance Specialist II will report to the Associate Director, Quality Assurance. The position will support the quality and regulatory compliance of commercial and clinical products including manufacturing, testing, and release at contract service providers.  Further, the position will be...

  • Quality Control Analytical Specialist

    7 days ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job OverviewPosition Title: Analytical Sciences & Technology Specialist ISalary: CompetitiveSummary:The Analytical Sciences & Technology Specialist I plays a pivotal role in the technical advancement of quality assurance methodologies and processes. This includes the validation of methods and instruments, as well as the technical transfer related to...

  • Quality Assurance Specialist

    1 day ago

    Philadelphia, Pennsylvania, United States Gift of Life Donor Program Full time

    Job SummaryWe are seeking an experienced Quality Assurance Coordinator to join our team at the Gift of Life Donor Program. As a Quality Assurance Coordinator, you will play a critical role in maintaining the quality of our organ and tissue donation processes.Key ResponsibilitiesQuality Assurance Review: Perform quality assurance review of organ and tissue...

  • 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...

  • Clinical Quality Assurance Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States InsideHigherEd Full time

    Clinical Quality Assurance SpecialistInstitution OverviewInsideHigherEd is a prominent entity in the educational sector, recognized for its commitment to fostering innovation and excellence in higher education. As a leader in providing insights and resources, it plays a crucial role in shaping the future of academic institutions and their workforce.At...

  • QMS Quality Control Specialist NSWCPD Code 00Q

    3 weeks ago

    Philadelphia, United States Orbis, Inc. Full time

    QMS Quality Control Specialist NSWCPD Code 00Q Philadelphia, PA Responsibilities: Position is for the Quality Control Specialist, NSWCPD Code 00Q support, to be part of team supporting Quality Assurance and Technical Administration Support services. This support will include supporting: Quality Management System Program, Systems Engineering Process (SEP)...

  • Quality Assurance Compliance Specialist

    7 days ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    Position Title: Quality Control Compliance Investigator IICompany: Planet PharmaLocation: Philadelphia, PAOverview:The Quality Control (QC) Compliance Investigator II will play a pivotal role in supporting the Laboratory Manager in the advancement and resolution of quality control-related investigations. Candidates should possess strong technical writing...