Position Title: Chemistry Data Reviewer

Description

SUMMARY:

• Will be performing chemistry data reviews - verify and sign off on the chemists results.
• Will start with verifying high volume tests and then verify more complex testing.
• They need to have experience with also working with HPLC and preferably LIMS and Empower Software.
• BS in Chemistry or related science with 3-5 years of analytical chemistry testing using HPLC and wet chemistry.

Position Summary:

• The QAO Chemistry Lab Data reviewer is responsible for reviewing an validating the data in lab notebooks, data print-out, lab test requests, assessments, reports, investigations, and controlled data sheets, and any electronic data, and audit trail generated by the B Braun QC Chemistry laboratories in Irvine.

Responsibilities: Essential Duties

• Work in the Quality Assurance Oversight team in the Chemistry labs and perform document technical review.
• Review and approve data per laboratory notebook and LIMS documentation.
• Technical review of test execution including all preparations, instrument setup, and data/result generation.
• Electronic review of chromatography in Empower software.
• Track review requirements for the released of finished products, Stability and raw materials lots.
• Participate on cross-functional teams to assist with the closure of chemistry related investigations.
• Review and draft investigations and risk-assessments in support of chemistry quality compliance.
• Perform in support of investigations, CAPAs and effectiveness checks, as related to product testing.
• Compile, review and interpret statistical data and information and present metrics.
• Perform administrative duties as required in support of chemistry related assessments and investigations.
• Benchmark and apply industry best practices.
• Review, compare and update current documentation of processes and equipment functionality/design to comply with FDA's Code of Federal Regulations 21 CFR Parts 210 and 211.

Additional Skills & Qualifications

• Bachelors degree in a scientific discipline- Chemistry preferred, open to Biochemistry or Biology
• Must have 3-5 years of experience using HPLC and or data review in a Pharma, BioTech or Med Device company.

Pay and Benefits

The pay range for this position is $40.00 - $48.00/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 Irvine,CA.

Application Deadline

This position is anticipated to close on May 15, 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 actalentaccommodation@actalentservices.com for other accommodation options.