SUMMARY OF POSITION

The Documentation Scientist provides support and oversight to Quality Control (QC) analysts through the review and witnessing of documentation produced by the QC laboratory.

ORGANIZATION STRUCTURE

The Documentation Scientist reports to the QC Manager.

RESPONSIBILITIES

Primary responsibilities of this role include the following

1. Documentation review
   1. Understand, review, and witness testing and other documentation for compliance to relevant SOPs, QATs, methods, etc.
   2. Work directly with QC analysts to resolve discrepancies, deviations, omissions, errors, etc. discovered in the course of review.
   3. Escalate outages to laboratory management as appropriate.
   4. Review and revise documents such as SOPs, QATs, methods, templates, etc. as needed.
   5. Perform final review of notebooks to facilitate closure.
2. Additional duties as assigned

QUALIFICATIONS

1. AS or BS in chemistry or related field, plus 3-5 years of pharmaceutical QC laboratory experience, or equivalent combination of education and experience.
2. Excellent oral and written communication skills.
3. Proficient in computer use (Word, Excel, PowerPoint, internet) with ability to learn new computer applications.
4. Ability to comprehend and follow standard operating procedures and test methods.
5. Strong attention to detail, especially with respect to written procedures, and ability to multitask.
6. Operates with a sense of urgency in a fast-paced environment.
7. Strong organization, communication, and interpersonal skills.

GMP DECISION-MAKING AUTHORITY

1. Review and approve laboratory documentation.
2. Identify documentation discrepancies and determine resolution.
3. Escalate discrepancies to laboratory management as appropriate.

This role will offer a base salary that is commensurate with experience and demonstrated skills in the $58,000.00 - $62,000.00 range.

"An Equal Opportunity Employer, including disability/vets."