QC Scientist II - Data Review

Actalent•Berkeley, MO

37d•$30 - $35•Onsite

About The Position

The Scientist II, Data Review will oversee the review of testing documents generated by the Quality Control Analytical department. The role involves managing program support needs, tracking timely delivery, and evaluating demand versus capacity. Additionally, the scientist will maintain electronic systems and collaborate with lab managers to resolve testing priorities and timelines.

Requirements

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

Nice To Haves

Knowledge of analytical techniques such as HPLC, UPLC, cIEF, CGE, DNA, ELISA, Bioassay Testing, etc. is preferred.
Strong presentation skills through various formats.

Responsibilities

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.
Interact with auditors and clients during visits and tours, as needed.
Assist in maintaining data integrity.
Perform other job duties as assigned.