Data Reviewer

04/19/2018

Data Reviewer
Pfizer- Lake Forest, IL

ROLE SUMMARY

Scientific and Laboratory Services Lake Forest Chemical Quality (SLS-CQ) laboratory tests L-Hospira product on stability as well as some release testing and other unique stability studies.

This individual will be required to review analytical data from wet chemical techniques including visual evaluation, titrations and pH as well as from instrumental techniques including AA, HPLC, GC and UV/Vis.

This individual must be able to use computer systems - including chromatographic data acquisition software, instrument software, excel and LIMS systems.

This individual must interact with laboratory analysts and laboratory supervisors to correct data through Good Documentation Practices, if required.

ROLE RESPONSIBILITIES

The primary responsibility of this role includes using Functional/Technical skills to perform review and approval of chemistry data and results in accordance with procedure, regulatory guidelines (FDA, MHRA, TGA, ICH, and DEA).

This individual will need to Act Decisively on the acceptability of test data (Empower chromatography and other analytical laboratory data) based on procedures and technical knowledge.

This individual needs to be Change Agile to schedule review activities to meet business needs and priorities with minimal assistance from management.

This individual may also perform duties in general support of the chemistry laboratory including sample receipt, monitoring laboratory metrics, assisting with investigations, and/or document change control.

This individual may be required to provide training or mentoring to fellow data reviewers or lab analysts.

QUALIFICATIONS

This individual must have a Bachelor’s degree in science discipline (preferably chemistry, biochemistry or biology).

This individual should have a minimum of 3-4 years experience in a Quality Control or R&D laboratory and experience with a wide variety of analytical techniques (e.g. HPLC, GC, AA, UV-Vis, etc.).

This individual should have knowledge of cGMPs and pharmaceutical regulations. Knowledge of LIMS, Empower, and Microsoft Office is desired.

PHYSICAL/MENTAL REQUIREMENTS

This individual will be required to sit at a desk and work on a computer for extended periods of time.

This individual will also be expected to perform some analytical laboratory activities during training.

This role also requires the ability to evaluate complex analytical data for accuracy and acceptability and also requires performing review of mathematical calculations.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

The typical work schedule is 1st shift, Monday-Friday. Overtime should not be used unless there are business critical needs and management pre-approval is obtained.

This individual will be required to wear a lab coat, closed toe shoes, and safety glasses when entering the laboratory.
ORGANIZATIONAL RELATIONSHIPS

This individual will primarily interact with internal colleagues and direct management.
EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

Additional Offer Details:

Last Date to Apply for Job: 4/30/2018
Additional Location Information: Lake Forest, IL
Eligible for Relocation Package

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Job Link:
https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/United-States---Illinois---Lake-Forest/Data-Reviewer_4696741-2?utm_source=Indeed&utm_medium=organic&utm_campaign=Indeed



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