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Data Reviewer

3 months ago

Orangeburg, United States PDI Full time

Driven by a commitment to research, quality and service, PDI provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team

**POSITION PURPOSE**

The purpose of this position is to review all analytical data (raw and electronic) and support the release of raw materials, bulk liquids, and/or finished goods. This position also performs data review of stability studies, R&D studies, cleaning studies, and any other data, as needed.

**ESSENTIAL FUNCTIONS AND BASIC DUTIES**
This position is responsible for performing the review of 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 and informing the QC Manager when tests are not within specified limits to take appropriate actions. Other key accountabilities specific to the function include:

- 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 including all tests according to the in-house monographs and USP in a regulated laboratory environment
- 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
- Performs other duties and projects as assigned by management

**PERFORMANCE MEASUREMENTS**
- On time review of analytical data resulting in few or no delays in product release
- First Time Right data review resulting in no nonconformities

**QUALIFICATIONS**

**EDUCATION/CERTIFICATION**:

- Bachelor’s degree in Chemistry or related field

**REQUIRED KNOWLEDGE**:

- Knowledge of all types of analytical instrumentation, software, and tests performed in the lab, including HPLC, GC, KF, Raw Materials, etc. is required.

**EXPERIENCE REQUIRED**:

- 4+ years related experience in pharmaceutical analysis
- cGMP/regulatory and data integrity experience is preferred

**SKILLS/ABILITIES**:

- Ability to understand SOPs, USP/NF procedures, and requirements.
- Ability to handle multiple responsibilities
- Ability to handle multiple projects at once, well developed writing skills, and ability to interact with senior management

**WORKING CONDITIONS**
- No hazardous or significantly unpleasant conditions.

**SALARY RANGE**
- $70,000 - $80,000 annually

**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.

LI-PDI

LI-Onsite

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Ho