Documentation Specialist 3

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

Additional Information

For more information, please contact

Akriti Gupta

(973) 967-3409

Morristown, NJ 07960