GMP Documentation Specialist & QA Liaison

Experic, LLC; Cranbury Township (NJ); On-site; USD 80,000 - 110,000; Full time

Job summary

Experic, LLC is seeking a Technical Writer to lead QMS documentation activities within Operations at our Cranbury, NJ site. You will partner with Manufacturing, Packaging, Warehouse, Facilities, and QA to draft, revise, route, and maintain controlled GMP documents and ensure inspection readiness.

The role requires strong technical writing, attention to detail, and knowledge of cGMP within a regulated CDMO environment, with the ability to coordinate cross-functional review and changes.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Technical Writing, or related field; equivalent experience may be considered.
• 3+ years in pharmaceutical/biotech/regulated GMP environment.
• Experience leading GMP investigations and RCA methodologies.
• Experience authoring and coordinating GMP documentation.
• Familiarity with cGMP, GDP, and FDA regulatory expectations.
• Experience with QMS and document control systems.

Responsibilities

• Leads deviation and CAPA root cause analysis for GMP investigations.
• Leads change control documentation activities for Operations.
• Drafts, revises, formats, and coordinates controlled GMP documents (SOPs, batch records, forms, work instructions, logbooks, protocols).
• Coordinates document review, approval, and implementation between Operations and QA.
• Ensures documentation reflects current practices and regulatory expectations.
• Supports document control activities in the electronic QMS and data integrity expectations.
• Assists with periodic reviews, revisions, obsolescence, and version control.
• Assists with audit readiness and continuous improvement initiatives.
• Maintains organized records and archives per procedures.

Skills

Technical writing

Attention to detail

Document formatting

Cross-functional collaboration

Regulatory compliance

GMP/audit readiness

Change control

Education

Bachelor's degree

Tools

QMS software

EDMS

Microsoft Office

Job description

Experic, LLC is seeking a Technical Writer to lead QMS documentation activities within Operations at our Cranbury, NJ site. You will partner with Manufacturing, Packaging, Warehouse, Facilities, and QA to draft, revise, route, and maintain controlled GMP documents and ensure inspection readiness.

The role requires strong technical writing, attention to detail, and knowledge of cGMP within a regulated CDMO environment, with the ability to coordinate cross-functional review and changes.