Documentation Specialist

Documentation Specialist at Insight Global Documentation Specialist at Insight Global in Akron, Pennsylvania Posted in 8 days ago.

Type:

full-time

Job Description:

We are seeking a detail-oriented Documentation Specialist to support operations within a pharmaceutical manufacturing environment. This individual will play a key role in ensuring accuracy, compliance, and audit readiness across batch documentation and records.

What You'll Do:

Review pilot plant records (MWIs, FRs, cleaning documentation, etc.) for completeness and adherence to GDP standards Route documentation through proper workflows for closure Maintain and update batch tracking spreadsheets Support batch review as a secondary signature when needed Assist with material receipt and removal activities tied to batch completion Update SOPs and documentation as required File and organize records in accordance with retention policies Help maintain audit readiness across documentation and processes

Required Qualifications:

High school diploma or equivalent Experience with document review or records management Strong attention to detail and organizational skills Proficiency with Microsoft Word and Excel Strong technical writing and documentation skills

Preferred Qualifications:

Experience in a pharmaceutical or regulated (GMP) environment

Compensation:

$25.70-$30.00/HR Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.