Pharmaceutical Data Reviewer - cGMP Compliance

Company: TTG Talent Solutions
Location: Coral Springs
Posted on: May 11, 2025

Job Description:

Pharmaceutical Quality Control - Data Reviewer

All the relevant skills, qualifications and experience that a successful applicant will need are listed in the following description.
Location: Coral Springs, FL
Type: On-site
Contract Type: Contract (Mid-level)
Schedule: Full-time - 2nd shift: 2:30pm-11:30pm
Salary: $32-$35/hr

If hired for the 2nd shift, you will initially be trained during the 1st shift (7:30 A.M. - 4:30 P.M. ) schedule. Once your training is complete, you will transition to your regular 2nd shift hours.

Job Summary
We're seeking a meticulous Data Reviewer to join a leading team in analytical quality assurance. This role is pivotal in maintaining the integrity of analytical data for pharmaceutical products through thorough documentation and adherence to regulatory guidelines. The ideal candidate thrives in a detail-oriented environment and brings a strong understanding of cGMP standards and pharmaceutical laboratory processes.

Key Responsibilities

Evaluate analytical test data for raw materials, in-process samples, finished products, and stability samples.
Review documentation from laboratory analysis using HPLC/UPLC, GC, KF, and other analytical techniques per in-house and USP monographs.
Ensure compliance with cGMP and SOPs in all data review activities.
Audit laboratory notebooks, data files, and electronic records for accuracy and regulatory compliance.
Assess instrument logs and audit trails for appropriate use and proper documentation.
Review and sign off on validation and method optimization reports.
Collaborate with chemists to ensure timely documentation corrections and compliance.
Support regulatory inspections and internal audits by preparing relevant documentation and data sets.
Investigate Out of Specification (OOS), Out of Trend (OOT), and other quality events.
Provide training and guidance on best practices for lab data recording and review.

Qualifications

Bachelor's degree in Chemistry or a related scientific field.
Minimum of 4 years' experience in a cGMP pharmaceutical environment.
Proficient in analytical instrumentation such as HPLC, GC, and Dissolution testers.
Strong understanding of regulatory expectations (USP, ICH, FDA).
Experience reviewing raw data, audit trails, and electronic data systems.
Clear communication skills, both written and verbal.
Proven ability to identify and correct documentation issues.
Highly organized with strong attention to detail.

Work Environment and Physical Demands

Standard office and laboratory environment.
Ability to stand, walk, and use hands for extended periods.
Occasional lifting of up to 15 lbs may be required.
ttg Talent Solutions is an Equal Opportunity Employer and recruiting agency. We are committed to creating an inclusive and diverse work environment and welcome applications from all qualified candidates regardless of race, color, religion, gender, sexual orientation, national origin, age, disability, or veteran status. Please note that all offers of employment are contingent upon the successful completion of a drug test and background check. We maintain a drug- and substance-free workplace to ensure the safety and well-being of all employees.
At ttg, "We believe in making a difference One Person at a Time," ttg OPT.

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Keywords: TTG Talent Solutions, Key Biscayne , Pharmaceutical Data Reviewer - cGMP Compliance, Healthcare , Coral Springs, Florida