Jobs
>
Philadelphia

    Quality Control Training Specialist II - Philadelphia, United States - Planet Pharma

    Show more Collapse job
    Default job background
    Description

    Overview

    The Quality Control Training Specialist II is responsible for establishing a formal training program and certification requirements for all QC Teams. The Training Specialist II is responsible for developing, conducting, and revising a QC training program on the methods used in the laboratories (Flow, EM, potency assays, etc.). They are responsible for ensuring training is completed in compliance with all applicable procedures, standards, and GMP regulations.

    Essential Functions and Responsibilities

    Identify training needs, devise an organizational training strategy and curriculum, oversee its implementation, evaluates effectiveness through competency testing, and establish a feedback loop to ensure continuous improvement.

    Develop a training schedule, coordinate the staffing and scheduling of in-house and field training.

    Plan curriculum design and support documentation, including drafting and approval of SOPs.

    Training and development of staff, including mentoring/coaching to motivate and mentor peers/ staff, to foster a culture of continuous improvement and operational excellence.

    Deliver training sessions and ensure training documentation is maintained. Ensure training schedules meet company production and quality targets.

    Continuously seek and support new approaches, practices, and processes to improve the efficiency and efficacy of training.

    Establish key performance indicators to measure training effectiveness.

    Create processes that enable timely and actionable performance feedback of trainees.

    Develop a comprehensive understanding of current production process, as this role is viewed as a subject matter expert within specific area.

    Ensure the department understands and complies with quality standards and requirements as documented.

    Must adhere to companies 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

    Minimum B.S. degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.

    Minimum of 5-10 years of experience in biopharmaceutical based GMP operations.

    Experience successfully working in an analytical role/level

    Knowledge and solid understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory

    Solid understanding of Quality systems

    Proficiency in basic and advanced analytical methodologies within a functional laboratory

    Solid understanding and functional knowledge in Flow Cytometry, Microbiology assays, cell counts, and/or potency assays

    Solid understanding and functional knowledge in Flow Cytometry, Microbiology assays, cell counts, and/or potency assays

    Proficient in performing technical writing (e.g., test methods, SOP's, protocols, etc.)

    Experience, training, or certification with Process Excellence tools and methodologies

    Experience with Quality Control document reviews and regulatory inspection processes

    Basic knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards

    Proficiency with Microsoft Office Suite (Outlook, Excel, Word, and PowerPoint)

    Requires ability and flexibility to work or support multiple shifts and provide occasional support on the weekends, as needed.

    Ability to deal with ambiguity ready to change gears and plans quickly, with the need to manage constant change.

    Ability to work successfully in a fast-paced team-oriented environment.

    Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.

    Excellent oral and written communication skills. Strong technical writing ability required.

    Preferred Education, Skills, and Knowledge

    Experience working in Biopharmaceutical or Pharmaceutical industry in Cell and/or Gene Therapy preferred.

    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.


    We have other current jobs related to this field that you can find below

  • Continental Tide

    Training Specialist

    5 days ago


    Continental Tide Philadelphia, United States

    Company Overview: · Continental Tide Defense Systems, Inc. (Continental Tide) is an industry leader, providing engineering and industrial services to the U.S. Navy, U.S. Coast Guard, Military Sealift Command, and other DoD organizations. At Continental Tide, we understand that a ...

  • Pyramid Consulting, Inc

    Training Specialist

    5 days ago


    Pyramid Consulting, Inc Camden, United States

    Immediate need for a talented Training Specialist. This is a 12+months contract opportunity with long-term potential and is located in Camden, NJ (Hybrid). Please review the job description below and contact me ASAP if you are interested. · Job ID: · Pay Range: $45 - $50/hour. E ...

  • Yoh

    Training Specialist

    1 week ago


    Yoh Philadelphia, United States

    Reference #: Training Specialist · Category: Life Science · Employment Type: Contract · Reference: BH · Training Specialist needed for a contract opportunity with Yoh Scientific's client located in Philadelphia, PA. · This position requires a Bachelor's of Science degree and ...

  • Iovance Biotherapeutics Inc

    Training Specialist

    4 weeks ago


    Iovance Biotherapeutics Inc Philadelphia, United States

    Job Description · Job DescriptionSalary: · Iovance is hosting an onsite Job Fair. · Where: Iovance Cell Therapy Center (iCTC) · Location: 300 Rouse Blvd Philadelphia, PA 19112 · Date: Monday, June 24, 2024 · Time: 12pm to 6pm (EDT) · What to bring: Updated resume · We are H ...


  • Omega Dynamics New Point, United States

    Sorting is not only important in Tetris, but also in logisticsAs a warehouse specialist, you contribute to ensuring that our customers receive their goods on time and in proper order. In your training in the transshipment warehouse and contract logistics, you will learn everythin ...


  • Nexus Innovations Wrightsville, United States

    Training as an IT specialist for system integration (m/f/d) in Wrightsville · START NOW - BECAUSE WE OFFER TRAINING ALL YEAR ROUND · Training as an IT specialist for system integration (m/f/d) at ATZ Group AG · The ATZ Group AG supports companies in finding digital solutions for ...


  • Geo-Technology Associates, Inc. Philadelphia, United States Full time

    Join the Geo-Technology Associates, Inc. (GTA) team as a dynamic Training & Development Specialist This hybrid role offers the flexibility to work from one of our offices in Northern Delaware, Maryland, or Eastern Pennsylvania. Reporting to the Director of Learning and Talent Dev ...

  • Pyramid Consulting

    Training Specialist

    6 days ago


    Pyramid Consulting Camden, United States

    Immediate need for a talented Training Specialist. This is a 12+months contract opportunity with long-term potential and is located in Camden, NJ (Hybrid). Please review the job description below and contact me ASAP if you are interested. · Job ID: · Pay Range: $45 - $50/hour. ...


  • Adare Pharma Solutions Philadelphia, United States

    Job Description · Job DescriptionAre you ready to join a growing, global drug development and manufacturing organization that puts people first? Come to Adare We work closely with our pharmaceutical industry partners during all phases of drug development with a mission of improvi ...


  • Adare Pharma Solutions Philadelphia, United States

    Are you ready to join a growing, global drug development and manufacturing organization that puts people first? Come to Adare We work closely with our pharmaceutical industry partners during all phases of drug development with a mission of improving the lives of patients and medi ...


  • Merakey Philadelphia, United States

    External Description · Are you looking for an opportunity to advance your career while working with an extraordinary team? At Merakey, we put heart and soul into everything we do. We are seeking anEmployment Training Specialist - Fee For Serviceto join our team at our program in ...


  • Playworks Philadelphia, United States

    ABOUT THE ROLE, as a Program Specialist you will help empower play in communities throughout our region by providing single or multi-day trainings, on-site service delivery, spreading awareness of Playworks through school outreach, and providing support for programming across PA. ...


  • Iovance Biotherapeutics, Inc. Philadelphia, United States

    Iovance is hosting an onsite Job Fair. · Where: Iovance Cell Therapy Center (iCTC) · Location: 300 Rouse Blvd Philadelphia, PA 19112 · Date: Monday, June 24, 2024 · Time: 12pm to 6pm (EDT) · What to bring: Updated resume · We are Hiring We look forward to seeing you at the ...


  • Adare Pharma Solutions Philadelphia, United States

    Are you ready to join a growing, global drug development and manufacturing organization that puts people first? Come to Adare We work closely with our pharmaceutical industry partners during all phases of drug development with a mission of improving the lives of patients and medi ...

  • Iovance Biotherapeutics Inc

    Training Specialist

    4 weeks ago


    Iovance Biotherapeutics Inc Philadelphia, United States

    **Iovance is hosting an onsite Job Fair.** · **Where**: _Iovance Cell Therapy Center (iCTC)_ · **Location**: _300 Rouse Blvd Philadelphia, PA 19112_ · **Date**:_ Monday, June 24, 2024_ · **Time**: _12pm to 6pm (EDT)_ · **What to bring**:U_pdated resume_ · **We are Hiring **We loo ...


  • Radiant Enterprises Aldan, United States

    Are you interested in a career in logistics? Do you have a knack for organization and a strong work ethic? Then we have the perfect opportunity for you · As an Aldan logistics specialist, you will be responsible for efficiently handling a wide variety of goods in our warehouse, w ...


  • MAXIMUS Philadelphia, United States

    Description & Requirements · Maximus is currently looking for a Training Specialist to join our team. This remote training specialist will be responsible for developing training curriculum and training materials with the goal of meeting program objectives and customer service l ...


  • Titan Ventures Glenolden, United States

    Training for Warehouse Logistics Specialist (m/f/d) in GlenoldenThe warehouse logistics specialist (m/f/d) is responsible for the proper storage of goods. In addition, they conduct quality checks on inventory and play a key role in inventories. Preferred areas of deployment inclu ...


  • Merakey Pennsylvania Philadelphia, United States

    Reference #: Requisition Number 88730 · City Philadelphia · Shift Various · External Description · Are you looking for an opportunity to advance your career while working with an extraordinary team? At Merakey, we put heart and soul into everything we do. We are seeking an Employ ...


  • Proclinical Philadelphia, United States Permanent

    QC Training Specialist - Permanent - Philadelphia, PAProclinical is seeking a dedicated QC Training Specialist. This is a permanent position located in Philadelphia, PA. · Primary Responsibilities:This role focuses on establishing a comprehensive training program and certificatio ...