Data Reviewer - 12pm to 8:30 pm Monday to Friday

Description

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 DUTIESThis 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. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)