QC Scientist II - Data Review

Overview

Manage QC analytical data review, ensure timely testing documentation and compliance.

Key Responsibilities

• client interaction
• data integrity
• test review
• issue resolution

Tasks

-Interact with auditors and clients during visits and tours, as needed. -Assist in maintaining data integrity. -Review testing carried out by labs, including routine testing, validation, and stability. -Efficiently communicate with peers, QA, and staff to ensure timely corrections of data, resolve issues, and identify when support is required.

Requirements

• hplc
• uplc
• cgmp
• ms project
• empower
• stem degree

What You Bring

-Ability to prioritize multiple timelines and coordinate reviews for multiple testing teams. -STEM degree preferred. -Strong presentation skills through various formats. -Prior use of EMPOWER is preferred. -Knowledge of analytical techniques such as HPLC, UPLC, cIEF, CGE, DNA, ELISA, Bioassay Testing, etc. is preferred. -Experience with MS Project, Excel, Word, and Smartsheet. -Bachelor’s degree with 1-3 plus years of relevant work experience required. -Understanding of cGMPs and Quality Control regulatory requirements. -Experience with multiple HPLC/UPLC assays including SEC, CEX, Glycans, Peptide Map, etc. -Minimum of 1-3 years of HPLC/UPLC experience in quality/analytical/pharmaceutical industry. -Working knowledge of scientific principles for a wide range of analytical techniques. -Knowledge of GMP regulations in a cGMP manufacturing environment. -Capable of working in a fast-paced environment with the ability to prioritize efficiently. -Proficiency in HPLC, GMP, and chemistry.

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Benefits

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

About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

Sector Specialisms