Documentation Specialist - Life Science

Documentation Specialist - Job Opportunity

Location : Fully Onsite in Lititz, PA

Hiring Method: 12 Month Contract-to-Perm

Shift: 1st Shift (M-F)

Compensation: $24.50/hr to $29.95/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.

Required Skills & Experience

• Bachelors degree
• Document Review experience
• Attention to Detail Competence in Word and Excel Knowledge
• Technical Writing
• Pharma background

Job Description

• Review pilot plant documentation (e.g., manufacturing work instructions, forms, cleaning records) to ensure accuracy, completeness, and compliance with good documentation practices (GDP)
• Route documentation through required workflows to support timely review, approval, and closure
• Maintain and update batch tracking tools to monitor production status and documentation progress
• Provide secondary verification/signature support for batch records as needed to ensure compliance
• Support material operations, including receipt of materials and removal of materials from inventory systems upon batch completion
• Update and maintain standard operating procedures (SOPs) to reflect current processes and regulatory requirements
• Organize and file documentation in accordance with record retention policies and audit standards
• Contribute to audit readiness by ensuring documentation is accurate, complete, and readily accessible