GxP Document Control Specialist - Flexible Schedule

Associates of Cape Cod Inc.; East Falmouth (MA); On-site; USD 54,000 - 62,000; Full time

Benefits offered by this job

401(k)

Dental insurance

Health insurance

Paid time off

Tuition reimbursement

Flexible schedule

Job summary

Associates of Cape Cod, Inc. (ACC) is seeking a Document Control professional to maintain and supervise controlled documents, logs, and archival processes in a GMP/ISO environment.

The role supports audits, training, and monthly quality reports while ensuring records are accurate and accessible. The position requires knowledge of cGMP and ISO 13485, an associate degree, and 1–3 years in FDA/ISO-regulated settings.

Qualifications

• Experience in cGMP and ISO 13485 document control is required.
• Detail oriented with strong organization and time management.
• Ability to collaborate in a fast paced team environment and meet deadlines.

Responsibilities

• Maintain all Document Control procedures and update activities.
• Manage document control databases and logs for accuracy.
• Maintain distribution logs and ensure proper issuance of controlled docs.
• Archive storage, retrieval, and offsite storage coordination.
• Prepare and release item masters and batch documentation as needed.
• Support audits, training, and monthly reporting related to Document Control.
• Assist in CTS reports and other Quality System assignments.

Skills

cGMP knowledge

ISO 13485

Document control

Detail oriented

Organizational skills

Multitasking

Communication skills

MS Office proficiency

Education

Associate degree or equivalent

1–3 years FDA/ISO regulated experience

Job description

Associates of Cape Cod, Inc. (ACC) is seeking a Document Control professional to maintain and supervise controlled documents, logs, and archival processes in a GMP/ISO environment.

The role supports audits, training, and monthly quality reports while ensuring records are accurate and accessible. The position requires knowledge of cGMP and ISO 13485, an associate degree, and 1–3 years in FDA/ISO-regulated settings.