Documentation Specialist III : 4529147

Artech Information System LLC; Framingham (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading IT company in Massachusetts is looking for a QC Documentation Specialist III. This role involves reviewing assay data, archiving QC documents, and training staff on document systems. The ideal candidate should have a degree in Life Sciences, 5+ years of relevant experience, and strong skills in HPLC and Empower software. Excellent communication skills are essential as the role requires collaboration and handling multiple document requests in a fast-paced environment.

Qualifications

• 5+ years of experience in a QC role or a master's degree and 3+ years.
• Experience with QA/QC data review in a regulated industry is essential.
• Knowledge of GDP and cGMP is necessary.

Responsibilities

• Review assay data for completeness according to SOPs, GDP, and regulatory standards.
• Archive and retrieve QC documents, maintain systems for document storage.
• Train employees on efficient system usage and interact with coworkers.

Skills

Detail-oriented

Strong interpersonal skills

Excellent oral communication

Excellent written communication

Highly organized

Experience with HPLC

Knowledge of FDA regulations

Education

Degree in Life Sciences discipline

Tools

Empower software

Job description

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.

Job Description

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

The individual will be responsible to review assay data for completeness in accordance with SOP s, GDP, and regulatory standards.

Must possess sound interpersonal and information gathering skills, and candidate is able to relate well with coworkers and at all levels throughout the organization.

Candidate is able to work in a team environment where collaboration and interaction is critical to work successfully.

Responsible for archiving and retrieval of QC documents, maintain systems for document storage and retrieval, and help train employees on efficient system usage.

The QC documentation Specialist may interpret and trend complex data.

Position is Monday to Friday

Skills:

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

Be highly organized and process-oriented.

They must have excellent oral and written communications skills to interact with all levels of the Quality organization.

They must have excellent listening skills, and be able to handle multiple requests while detailing document activity

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

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

Knowledge of FDA regulations, GDP, and cGMP.

Preferred Qualifications:

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

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

Qualifications

Degree in the Life sciences discipline, Bachelor degree and 5+ years of experience, or a master degree and 3+ years of experience