Quality Operations Specialist II

1 month ago


Philadelphia, United States ProClinical Full time
Quality Operations Specialist II - Night Shift - Contract - Philadelphia, PA

Proclinical is seeking a dedicated Quality Operations Specialist II to join an established biotech. This position is crucial for maintaining compliance with current Good Manufacturing Practices (cGMPs) and facility procedures.

Primary Responsibilities:

The successful candidate will interface with various functional groups, such as Manufacturing, Quality Control, and Document Control, to identify and report events like errors, deficiencies, discrepancies, deviations, and other observations to management.

Skills & Requirements:
  • Bachelor's Degree in Science, Engineering, or a related technical discipline, or equivalent industry experience.
  • Working knowledge of Good Manufacturing Practices (cGMPs) regulations.
  • Ability to work in an aseptic processing environment.
  • Strong administrative skills, including proficiency in Microsoft Word, Excel, and PowerPoint.
  • Excellent attention to detail.
  • Knowledge of QMS systems is a plus.

The Quality Operations Specialist II's responsibilities will be:
  • Maintain strict adherence to Good Manufacturing Practices (cGMPs) and facility protocols.
  • Interface with Manufacturing, Quality Control, and Document Control to identify and report events such as errors, deficiencies, discrepancies, deviations, and other observations to management.
  • Review batch records and related production documentation, resolving identified issues before product disposition.
  • Collaborate with internal functions to address issues promptly.
  • Disposition incoming raw materials.
  • Apply quality compliance theories and principles to address issues independently.
  • Provide guidance on controlled documents, identifying gaps, and suggesting process improvements.
  • Maintain and report on Quality Metrics.
  • Initiate and participate in SOP revisions to improve compliance.

Compensation:
  • USD 30-40 per hour

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

  • philadelphia, United States Proclinical Staffing Full time

    Quality Operations Specialist II - Night Shift - Contract - Philadelphia, PAProclinical is seeking a dedicated Quality Operations Specialist II to join an established biotech. This position is crucial for maintaining compliance with current Good Manufacturing Practices (cGMPs) and facility procedures. Primary Responsibilities:The successful candidate will...


  • Philadelphia, United States Proclinical Staffing Full time

    Quality Operations Specialist II - Night Shift - Contract - Philadelphia, PAProclinical is seeking a dedicated Quality Operations Specialist II to join an established biotech. This position is crucial for maintaining compliance with current Good Manufacturing Practices (cGMPs) and facility procedures. Primary Responsibilities:The successful candidate will...


  • philadelphia, United States Proclinical Staffing Full time

    Quality Operations Specialist II - Night Shift - Contract - Philadelphia, PAProclinical is seeking a dedicated Quality Operations Specialist II to join an established biotech. This position is crucial for maintaining compliance with current Good Manufacturing Practices (cGMPs) and facility procedures. Primary Responsibilities:The successful candidate will...


  • Philadelphia, Pennsylvania, United States H2 Performance Consulting Full time

    H2 Performance Consulting is an Equal Opportunity/Affirmative Action Employer and strives to build a diverse workforce.We are seeking a highly skilled Cybersecurity Specialist II to support the Naval Surface Warfare Center Philadelphia Division (NSWCPD) Code 20 Land Based Test Site Programs.The successful candidate will provide ISSE support across all IT and...


  • Philadelphia, United States Proclinical Staffing Full time

    QA Specialist II, Cell Therapy - Contract - Philadelphia, PAProclinical is seeking a highly motivated QA Specialist II to join the Quality Operations team for a night shift role. This position involves ensuring compliance with cGMP regulations and internal policies, working closely with manufacturing personnel to maintain high standards of work....


  • philadelphia, United States Planet Pharma Full time

    615203 Quality Control Specialist II, Sterility AssuranceDirect HirePhiladelphia, PAMicrobiology experienceGood Aseptic gowning background/experienceContamination experienceManufacturing/GMP experienceOverview The Quality Control Specialist, Sterility Assurance is responsible for effectively collaborating with multiple stakeholders to ensure the harmonized...


  • Philadelphia, United States Planet Pharma Full time

    615203 Quality Control Specialist II, Sterility AssuranceDirect HirePhiladelphia, PAMicrobiology experienceGood Aseptic gowning background/experienceContamination experienceManufacturing/GMP experienceOverview The Quality Control Specialist, Sterility Assurance is responsible for effectively collaborating with multiple stakeholders to ensure the harmonized...

  • Quality Specialist

    2 weeks ago


    philadelphia, United States Scienta Full time

    Role – QA Specialist Location – Pennsylvania Working type – Permanent Hours – 9-5 (Mon to Friday) Company: Scienta are proud to be partnering with Philadelphia’s leading CDMO in their Quality expansion. They focus on developing and manufacturing Cell and Gene Therapy products which are marketed across the globe and want an ambitious Quality...

  • Quality Specialist

    3 weeks ago


    philadelphia, United States Scienta Full time

    Role – QA Specialist Location – Pennsylvania Working type – Permanent Hours – 9-5 (Mon to Friday) Company: Scienta are proud to be partnering with Philadelphia’s leading CDMO in their Quality expansion. They focus on developing and manufacturing Cell and Gene Therapy products which are marketed across the globe and want an ambitious Quality...

  • Quality Specialist

    3 weeks ago


    Philadelphia, United States Scienta Full time

    Role – QA Specialist Location – Pennsylvania Working type – Permanent Hours – 9-5 (Mon to Friday) Company: Scienta are proud to be partnering with Philadelphia’s leading CDMO in their Quality expansion. They focus on developing and manufacturing Cell and Gene Therapy products which are marketed across the globe and want an ambitious Quality...


  • philadelphia, United States Randstad USA Full time

    In this role you will be responsible for the interpretation of AML Risk standards, guidelines, policies and procedures. You will review flagged alerts and determine if the account should be closed out or if the account can remain open. Additionally, you will make a risk based determination through Quality Analysis whether alerts were properly cleared by...


  • Philadelphia, United States Randstad USA Full time

    In this role you will be responsible for the interpretation of AML Risk standards, guidelines, policies and procedures. You will review flagged alerts and determine if the account should be closed out or if the account can remain open. Additionally, you will make a risk based determination through Quality Analysis whether alerts were properly cleared by...


  • philadelphia, United States Randstad USA Full time

    In this role you will be responsible for the interpretation of AML Risk standards, guidelines, policies and procedures. You will review flagged alerts and determine if the account should be closed out or if the account can remain open. Additionally, you will make a risk based determination through Quality Analysis whether alerts were properly cleared by...


  • philadelphia, United States Proclinical Staffing Full time

    QA Specialist II, Cell Therapy - Contract - Philadelphia, PAProclinical is seeking a highly motivated QA Specialist II to join the Quality Operations team for a night shift role. This position involves ensuring compliance with cGMP regulations and internal policies, working closely with manufacturing personnel to maintain high standards of work....


  • philadelphia, United States Proclinical Staffing Full time

    QA Specialist II, Cell Therapy - Contract - Philadelphia, PAProclinical is seeking a highly motivated QA Specialist II to join the Quality Operations team for a night shift role. This position involves ensuring compliance with cGMP regulations and internal policies, working closely with manufacturing personnel to maintain high standards of work....


  • 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...


  • Philadelphia, Pennsylvania, United States Meet Full time

    Job Title: Quality Assurance SpecialistJob Summary:Meet is seeking a Quality Assurance Specialist to ensure the quality and compliance of our products throughout the development and manufacturing processes. As a Quality Assurance Specialist, you will collaborate with cross-functional teams to implement quality assurance strategies, conduct risk assessments,...


  • 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...

  • Clinical Assistant II

    4 weeks ago


    Philadelphia, Pennsylvania, United States Solis Mammography Full time

    Job Summary:Clinical Assistant II - Patient Care SpecialistSolis Mammography is seeking a highly skilled and compassionate Clinical Assistant II - Patient Care Specialist to join our team. As a Clinical Assistant II - Patient Care Specialist, you will play a vital role in providing exceptional patient care and support in our breast health services.Key...

  • Analytical Sciences

    3 weeks ago


    Philadelphia, United States Iovance Biotherapeutics, Inc. Full time

    The Analytical Sciences & Technology Specialist II Specialist is accountable for the technical development of quality control methods and processes, method and instrument validations, and technical transfers related to Analytical and/or Microbiological quality control testing of products, raw materials, and packaging components at the site. This role is...