Data Review Specialist

4 days ago

Orangeburg, South Carolina, United States PDI Full time
Job Title: Data Review Specialist

PDI is seeking a highly skilled Data Review Specialist to join our team. As a Data Review Specialist, you will be responsible for reviewing analytical data and supporting the release of raw materials, bulk liquids, and/or finished goods.

Key Responsibilities:
  • Review all analytical reports and raw and electronic data from NY Quality Control (QC) including raw materials, finished products, stability study samples, packaging materials, in-process materials, cleaning analysis, and/or equipment calibration.
  • Inform the QC Manager when tests are not within specified limits to take appropriate actions.
  • Review and approve all tests results, including raw data and electronic data generated in support of testing of raw materials, in-process, finished product and/or stability samples.
  • Review all validation and method optimization reports.
  • Review all laboratory notebooks for correctness of raw data and verify all reagents, standards and equipment used are within the acceptable range.
  • Ensure chemists follow all SOPs and cGMP regulations and use the correct method or procedure for each product.
  • Ensure all testing/analysis is conducted according to approved test methods, standard operating procedures and/or associated documents and meets the product specific requirements.
  • Ensure notebooks are reviewed in a timely manner, in accordance with SOPs. Sign off on all analytical test results and reports.
  • Support QC and QA managements during regulatory, customer, corporate, and internal audits.
  • Work with analysts for document corrections and provide guidance accordingly. Guide analysts on laboratory notebook documentation requirements.
  • Analyze and interpret results in written and oral format.
  • Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices.
Requirements:
  • Bachelor's degree in Chemistry or related field.
  • 4+ years related experience in pharmaceutical analysis.
  • cGMP/regulatory and data integrity experience is preferred.
Benefits:

PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes:

  • Medical, behavioral & prescription drug coverage.
  • Health Savings Account (HSA).
  • Dental.
  • Vision.
  • 401(k) savings plan with company match and profit sharing.
  • Basic and supplemental Life and AD&D insurance.
  • Flexible Spending Accounts (FSAs).
  • Short & long-term disability.
  • Employee Assistance Program (EAP).
  • Health Advocacy Program.

PDI also offers many voluntary benefits such as:

  • Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.

At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including:

  • sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.

  • Data Review Specialist

    7 days ago

    Orangeburg, South Carolina, United States PDI Full time

    Job Title: Data Review SpecialistPDI is seeking a highly skilled Data Review Specialist to join our team. As a Data Review Specialist, you will be responsible for reviewing analytical data and ensuring compliance with regulatory requirements.Key Responsibilities:Review and approve analytical reports and raw dataEnsure compliance with cGMP regulations and...

  • Data Review Specialist

    5 hours ago

    Orangeburg, South Carolina, United States PDI Full time

    Job Title: Data Review SpecialistPDI is seeking a highly skilled Data Review Specialist to join our team. As a Data Review Specialist, you will be responsible for reviewing analytical data and ensuring compliance with regulatory requirements.Key Responsibilities:Review and validate analytical data from various sources, including raw materials, finished...

  • Data Review Specialist

    12 hours ago

    Orangeburg, South Carolina, United States PDI Full time

    Job Title: Data ReviewerPDI is seeking a highly skilled Data Reviewer to join our team. As a Data Reviewer, you will play a critical role in ensuring the accuracy and integrity of analytical data.Job Summary:The Data Reviewer will be responsible for reviewing all analytical data, including raw and electronic data, to ensure compliance with regulatory...

  • Data Review Specialist

    4 days ago

    Orangeburg, South Carolina, United States PDI Full time

    Job Title: Data ReviewerPDI is seeking a highly skilled Data Reviewer to join our team. As a Data Reviewer, you will play a critical role in ensuring the accuracy and integrity of analytical data.Job SummaryThe Data Reviewer will be responsible for reviewing all analytical data, including raw and electronic data, to ensure compliance with regulatory...

  • Data Review Specialist

    5 days ago

    Orangeburg, South Carolina, United States Nice-Pak Full time

    Job Title: Data ReviewerAt PDI, we are seeking a highly skilled Data Reviewer to join our team. As a Data Reviewer, you will play a critical role in ensuring the accuracy and integrity of our analytical data.Job Summary:The Data Reviewer will be responsible for reviewing all analytical data, including raw and electronic data, to ensure compliance with...

  • Data Specialist for Collective Impact

    1 day ago

    Orangeburg, South Carolina, United States Claflin University Full time

    Job Title: Data Specialist for Collective ImpactClaflin University is seeking a highly skilled Data Specialist to support the Collective Impact project in Orangeburg County. The successful candidate will play a critical role in monitoring the Rural Accelerator Initiative (RAI) and will be responsible for defining and maintaining data and knowledge management...

  • Data Specialist for Collective Impact

    1 week ago

    Orangeburg, South Carolina, United States Claflin University Full time

    Job DetailsClaflin University is seeking a highly skilled Data Specialist to support the Collective Impact project in Orangeburg County.Job SummaryThe successful candidate will oversee all data collection systems for the Rural Accelerator Initiative and provide data analysis and reporting support. This role requires strong data management and analytical...

  • Data Analyst

    2 weeks ago

    Orangeburg, South Carolina, United States Claflin University Full time

    About the RoleClaflin University is seeking a highly skilled Data Analyst to join our team as a Collective Impact Specialist. This is an exciting opportunity to work on a project that aims to monitor the Rural Accelerator Initiative in Orangeburg County.Key ResponsibilitiesData Management: Oversee all data collection systems for the Rural Accelerator...

  • Data Insights Specialist

    3 weeks ago

    Orangeburg, South Carolina, United States InsideHigherEd Full time

    Job SummaryWe are seeking a highly skilled Data Analyst to join our team at InsideHigherEd. The successful candidate will be responsible for coordinating programs, research, and evaluation components, as well as maintaining program records and ensuring consistent and efficient data collection and management.Key ResponsibilitiesCoordinate research and...

  • Office Administrative Support Specialist

    4 weeks ago

    Orangeburg, South Carolina, United States Love's Home Health Care Full time

    Job OverviewWe are seeking a dedicated individual to join our team as an Office Administrative Support Specialist. This role is essential in ensuring the smooth operation of our office and supporting our mission to provide high-quality care.Key Responsibilities:Manage incoming phone calls, including prescreening potential clients and caregivers.Perform data...

  • Student Retention Support Specialist

    4 weeks ago

    Orangeburg, South Carolina, United States Claflin University Full time

    Job OverviewLocation Claflin University Main Campus Employment Type Full Time Educational Requirement Bachelor's Degree Travel Requirement Up to 25% Work Schedule Day Shift Field Education Position SummaryKey Responsibilities The Student Retention Support Specialist reports directly to the Assistant Vice President for Student Development and plays a crucial...

  • Student Retention Support Specialist

    3 weeks ago

    Orangeburg, South Carolina, United States Claflin University Full time

    Job OverviewLocation Claflin University Main Campus Employment Type Full-Time Required Education Bachelor's Degree Travel Requirements Up to 25% Work Schedule Daytime Hours Category Education Position SummaryKey Responsibilities The Student Retention Support Specialist reports directly to the Assistant Vice President for Student Development and is dedicated...

  • Cyberinfrastructure Specialist

    4 weeks ago

    Orangeburg, South Carolina, United States Claflin University Full time

    Job OverviewPosition SummaryClaflin University is in search of a Cyberinfrastructure Specialist who will act as a key intermediary between the Information Technology department and researchers. This role is essential in collaborating with faculty, staff, and students to pinpoint resources, disseminate information, and explore available research...

  • Degree Completion Specialist

    5 days ago

    Orangeburg, South Carolina, United States Claflin University Full time

    Job Title: Stop-Out Prevention SpecialistJob Summary:The Stop-Out Prevention Specialist plays a critical role in supporting students who may be at risk of not completing their degree. This position requires a strong understanding of student development theory and current stop-out prevention methodologies.Key Responsibilities:Coordinate and implement stop-out...

  • GIS Administrator

    6 days ago

    Orangeburg, South Carolina, United States Department of Public UtilitiesCity of Orangeburg Full time

    Job SummaryWe are seeking a highly skilled GIS Administrator to join our team at the Department of Public Utilities/City of Orangeburg. The successful candidate will be responsible for administering Geographic Information System (GIS) and related databases, providing technical support, and managing GIS servers and software.Key ResponsibilitiesDevelop and...

  • Traveling CT Imaging Specialist

    4 weeks ago

    Orangeburg, South Carolina, United States Aequor Allied Full time

    Aequor Allied is currently in search of a traveling CT Imaging Specialist for an exciting opportunity. Position Overview & RequirementsSpecialty: CT Imaging SpecialistField: Allied Health ProfessionalDuration: 13 weeks36 hours per weekShift Length: 12 hoursEmployment Type: TravelAre you interested in a rewarding Travel CT Imaging Specialist position? Aequor...

  • Senior Cash Management Specialist

    4 weeks ago

    Orangeburg, South Carolina, United States Claflin University Full time

    Job OverviewLocation Claflin University Main Campus Employment Type Full-Time Travel Requirements Up to 25% Work Schedule Day Shift Department Accounting Position SummaryThe Senior Cash Management Specialist plays a pivotal role under the supervision of the Student Accounts Supervisor. This position is accountable for overseeing all cash handling operations...

  • Traveling CT Imaging Specialist

    4 weeks ago

    Orangeburg, South Carolina, United States Arrow Healthcare Staffing Full time

    Arrow Healthcare Staffing is actively seeking a traveling CT Imaging Specialist for an exciting opportunity. Position Overview & RequirementsSpecialty: CT Imaging SpecialistDiscipline: Allied Health ProfessionalDuration: 13 weeks36 hours per weekShift: 12 hours, daysEmployment Type: TravelIf you are in search of a rewarding Travel CT Imaging Specialist...

  • Quality Assurance Specialist

    2 weeks ago

    Orangeburg, South Carolina, United States Syngenta Biologicals Full time

    {"title": "Quality Control Specialist", "company": "Syngenta Biologicals", "location": "Orangeburg, SC", "job_description": "Job SummaryWe are seeking a Quality Control Specialist to join our Valagro Manufacturing team in Orangeburg, SC. As a key member of our team, you will be responsible for ensuring the quality of our products by conducting analytical...

  • Loan Processing Specialist

    4 weeks ago

    Orangeburg, South Carolina, United States LoanBud Full time

    Job DescriptionAbout the Role LoanBud is expanding, and we have an exciting opportunity for a dedicated individual to become part of our dynamic team. Our mission is to assist small enterprises in securing the financing necessary for their success, while providing a fulfilling career with opportunities for professional advancement and a collaborative work...