Documentation Specialist III

At the dawn of the new millennium, a unique information technology company was born: HCL Technologies. As narrated in the video below, HCL Technologies has demonstrated remarkable growth through the recent economic downturn, emerging as one of only eight 21st century listed technology companies in the world to cross $1bn in Net Profit, $6bn in Revenue and $15bn in Market Capitalization.

The Quality Control Chemistry Laboratory is seeking a candidate to fill a QC Documentation Specialist III position.

The individual will be responsible for reviewing assay data for completeness in accordance with SOPs, GDP, and regulatory standards.

The candidate must possess sound interpersonal and information gathering skills, and be able to relate well with coworkers and all levels throughout the organization.

The candidate should be able to work in a team environment where collaboration and interaction are critical to success.

Responsibilities include archiving and retrieval of QC documents, maintaining systems for document storage and retrieval, and helping to train employees on efficient system usage.

The QC Documentation Specialist may interpret and trend complex data.

Position is Monday to Friday.

Must be detail-oriented and able to work with a high volume of documents in a fast-paced environment.

Must be highly organized and process-oriented.

Excellent oral and written communication skills are required to interact with all levels of the Quality organization.

Excellent listening skills are necessary, along with the ability to handle multiple requests while detailing document activity.

Experience with HPLC (reversed phase and gradient) chromatography and Empower software or equivalent is required.

Experience with QA/QC data review in a regulated industry is necessary.

Knowledge of FDA regulations, GDP, and cGMP is essential.

Knowledge of SDS-Page, UV-Vis spectrometry (Spectra max plate analysis), and Ion Exchange chromatography (Dionex) is a plus.

Experience working in a QC Laboratory environment, completing testing, and/or QA or QC data review role is an advantage.

A degree in the Life sciences discipline, a Bachelor's degree with 5+ years of experience, or a Master's degree with 3+ years of experience is required.