"Alerted.org

Description

SUMMARY:

+ BS in Chemistry or related science with 3-5 years of analytical chemistry testing using HPLC and wet chemistry.

+ 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.

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.

Training: Training first few weeks SOP readings, partner with GMP trainer before they do any kind of reviews. Phase approach to simple testing to complicated testing high volume test basic wet chem tests (titrations, Limit testing, PH testing)=- need a lot of support. 30% of HPLC instrumentation analysis. FTIR Karl Fischer, IR, 2-3 weeks of training simple wet chem tests SOP readings. Varies (testing #) Finished product releases, review set volume, QC test samples, raw materials, daily activities, standard testing.

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/UPLC with Method transfer and development experience in a Pharma, BioTech or Med Device company.

Expertise: Knowledge & Skills

• Accuracy - Ability to perform work accurately and thoroughly.

• Analytical Skills - Ability to use thinking and reasoning to solve a problem.

• Communication, Oral & Written - Ability to communicate effectively with others using the spoken word

• and in composing clear and concise messages

• Conceptual Thinking - Ability to think in terms of abstract ideas.

• Customer Oriented - Ability to take care of the customers' needs while following company procedures.

• Decision Making - Ability to make decisions for a course of action to be taken to address a specific issue.

• Detail Oriented - Ability to pay attention to the minute details of a project or task.

• Organized - Possessing the trait of being organized or following a systematic method of performing a task.

• Problem Solving - Ability to solve problems by weighing all the variables to come up with a resolution

• Hands on chemistry lab experience preferred with working knowledge of GxP requirements

Experience Level

Expert Level

Job Type & Location

This is a Contract position based out of Irvine, CA.

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 Nov 28, 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 [email protected] (%[email protected]) for other accommodation options.