QC Scientist Reviewer

The role of the Data Reviewer involves meticulous examination of all analytical reports and raw and electronic data from CMC, including materials and equipment calibration. The position is crucial in ensuring that tests are within specified limits, and requires coordination with the CMC Manager and QA for appropriate actions when necessary.

Responsibilities

• Ensure analytical data meets company standards and regulatory requirements.
• Review test results and raw data for various materials and stability samples, including assays, chromatographic purity, content uniformity, particle size distribution, density, and water determination.
• Check laboratory notebooks and associated documents for correctness and verify all reagents, standards, and equipment used.
• Review raw data for audit trails and instrument logs on cGMP instrumentation and equipment.
• Review validation and method optimization reports.
• Ensure chemists follow SOPs and cGMP regulations and use correct methods for each product.
• Promptly review notebooks and sign off on all analytical test results and reports.
• Analyze and interpret results in written and oral formats.
• Work with analysts for document corrections and provide guidance on laboratory notebook documentation requirements.
• Follow SOPs and Safety Guidelines to ensure compliance with cGMP environment and Safety Practices.
• Provide support during regulatory and internal audits.
• Review Laboratory Incidents, OOS, OOT, and OOE investigations.
• Perform additional tasks as assigned by the QA supervisor.

• Bachelor's degree in Chemistry or related field.
• 4+ years of related experience in pharmaceutical analysis.
• Experience with various analytical instrumentation, software, and tests performed in the lab, including HPLC, GC, Dissolution, Raw Materials, etc.
• Understanding of SOPs, USP/NF procedures, and requirements.
• Previous cGMP/regulatory experience preferred.

• Proficiency in chemistry, quality control, data review, and quality assurance.
• Knowledge of LC, GC, CAPA, and Change Controls.

This position is generally performed in a GMP lab environment and office space. Physical requirements include standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking, and hearing. Occasionally, bending, kneeling, crouching, stooping, and crawling may be required. The role may require lifting up to 15 pounds occasionally.

The pay range for this position is $32.00 - $35.00/hr.

Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:

Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long-term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Boca Raton,FL.

Application Deadline

This position is anticipated to close on Jul 9, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email ... for other accommodation options.