Data Reviewer

POSITION PURPOSE

The purpose of the Data Reviewer 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

• This role is primarily based in an office setting within a warehouse and laboratory environment. The nature of this role may require extended hours on occasion. A significant portion of the workday will involve sitting at a desk, using a computer, and typing. This position involves repetitive tasks such as extensive typing and writing.
• No hazardous or significantly unpleasant conditions.

SALARY RANGE

• $70,000 - $75,000 annually

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

• Medical & prescription drug coverage
• Dental / Vision plan
• 401(k) savings plan with company match
• Basic and supplemental life insurance
• Flexible Spending Accounts (FSAs)
• Short- and long-term disability benefits
• Health Advocacy Program / Employee Assistance Program (EAP)

Many other voluntary benefit plans such as: Legal assistance, critical illness, hospital indemnity and accident coverage, discounted home/auto/rental insurance, employee discounts and pet insurance

At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide:  Sick leave, generous vacation and holiday time, paid parental leave, summer hours, flex place/flex time options

Salary : $70,000 - $75,000